Assessing the potential for patient-led surveillance after treatment of localized melanoma: A pilot randomized controlled trial (the MEL-SELF pilot trial)

Deonna M. Ackermann; Mbathio Dieng; Ellie  Medcalf; Cathelijne H. van Kemenade; Marisa C  Jenkins; Monika Janda; Robin M. Turner; Anne E. Cust; Rachael L. Morton; Rachael L. Morton; Les Irwig; Les Irwig; Pascale Guitera; H. Peter Soyer; Victoria Mar; Jolyn K. Hersch; Donald Low; Cynthia Low; Robyn P.M. Saw; Richard A. Scolyer; Dorothy Drabarek; David Espinoza; Anthony Azzi; Alister Lilleyman; Amelia K. Smit; Peter Murchie; John F. Thompson; Katy J.L. Bell

doi:10.1001/jamadermatol.2021.4704

Assessing the potential for patient-led surveillance after treatment of localized melanoma: A pilot randomized controlled trial (the MEL-SELF pilot trial)

Deonna M. Ackermann, Mbathio Dieng, Ellie Medcalf, Cathelijne H. van Kemenade, Marisa C Jenkins, Monika Janda, Robin M. Turner, Anne E. Cust, Rachael L. Morton, Rachael L. Morton, Les Irwig, Les Irwig, Pascale Guitera, H. Peter Soyer, Victoria Mar, Jolyn K. Hersch, Donald Low, Cynthia Low, Robyn P.M. Saw, Richard A. ScolyerDorothy Drabarek, David Espinoza, Anthony Azzi, Alister Lilleyman, Amelia K. Smit, Peter Murchie, John F. Thompson, Katy J.L. Bell^* (Corresponding Author)

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

Importance Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma.

Objective To determine whether patient-led surveillance compared with clinician-led surveillance in patients with prior localized primary cutaneous melanoma is safe, feasible and acceptable.

Design Randomized controlled trial.

Setting Two specialist-led clinics in metropolitan Sydney and a primary care skin cancer clinic run by general practitioners in metropolitan Newcastle.

Participants 100 patients previously treated for localized melanoma, who owned a
smartphone, had a partner to assist with skin self-examination (SSE), and were attending routinely scheduled follow-up.

Intervention Participants were randomized (1:1) to six months of patient-led surveillance (intervention: usual care plus reminders to perform SSE, patient performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (control: usual care).

Main outcomes and measures The primary outcome was the proportion of eligible
18 and contacted patients who were randomized. Secondary outcomes included
patient-reported outcomes (SSE knowledge, attitudes and practice, psychological outcomes, other healthcare use) and clinical outcomes (clinic visits, skin surgeries, subsequent new primary or recurrent melanoma).

Results

Between November 2018 and May 2019, 326 patients were found to be
eligible and contacted, and 100 (31%; 95%CI:26% to 36%) were randomized to patient-led surveillance (n=49) or clinician-led surveillance (n=51). Data were available on patient-reported outcomes for 66 participants, and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance increased SSE frequency and thoroughness, had no detectable effect on psychological outcomes, but did increase clinic visits, skin lesion excisions, and subsequent new primary melanoma diagnoses. New primary melanomas and one local recurrence were diagnosed in 8 intervention group participants (16%) including 5 at unscheduled visits (10%), and 3 control group participants (6%), with none at unscheduled visits (0%) (between-group difference: 10%; 95%CI: 2% to 19%).

Conclusion Patient-led surveillance following treatment of localized melanoma appears safe, feasible and acceptable. Difficulties that some participants experienced with adherence, response to questionnaires, and retention in the trial, as well the potential of the intervention to cause medical overuse, have prompted changes to trial processes for a larger trial of the same intervention.

Original language	English
Pages (from-to)	33-42
Number of pages	11
Journal	JAMA Dermatology
Volume	158
Issue number	1
Early online date	24 Nov 2021
DOIs	https://doi.org/10.1001/jamadermatol.2021.4704
Publication status	Published - 1 Jan 2022

Bibliographical note

JFT is a recipient of an NHMRC Program Grant (1093017). RPMS is supported by Melanoma Institute Australia. RAS is supported by an
408 NHMRC Practitioner Fellowship Grant (1141295). Support from colleagues at
Melanoma Institute Australia and Royal Prince Alfred Hospital is also gratefully acknowledged. RLM is supported with an NHMRC Investigator grant (1194703).
HPS holds NHMRC grants (1062935, 1099021,1137127) MJa was supported by an
NHMRC TRIP Fellowship 2018-20 (1151021). JH is supported by an NHMRC Early Career Fellowship (1112509). KLJB is supported by an NHMRC Investigator Grant 21(1174523), The MELSELF pilot RCT was funded through a NHMRC Project grant (1163054), a NHMRC Program grant (402764), and Friends of Mater Research Foundation (2016, 2017) grants.

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Ackermann, D. M., Dieng, M., Medcalf, E., van Kemenade, C. H., Jenkins, M. C., Janda, M., Turner, R. M., Cust, A. E., Morton, R. L., Morton, R. L., Irwig, L., Irwig, L., Guitera, P., Soyer, H. P., Mar, V., Hersch, J. K., Low, D., Low, C., Saw, R. P. M., ... Bell, K. J. L. (2022). Assessing the potential for patient-led surveillance after treatment of localized melanoma: A pilot randomized controlled trial (the MEL-SELF pilot trial). JAMA Dermatology, 158(1), 33-42. https://doi.org/10.1001/jamadermatol.2021.4704

Ackermann, DM, Dieng, M, Medcalf, E, van Kemenade, CH, Jenkins, MC, Janda, M, Turner, RM, Cust, AE, Morton, RL, Morton, RL, Irwig, L, Irwig, L, Guitera, P, Soyer, HP, Mar, V, Hersch, JK, Low, D, Low, C, Saw, RPM, Scolyer, RA, Drabarek, D, Espinoza, D, Azzi, A, Lilleyman, A, Smit, AK, Murchie, P, Thompson, JF & Bell, KJL 2022, 'Assessing the potential for patient-led surveillance after treatment of localized melanoma: A pilot randomized controlled trial (the MEL-SELF pilot trial)', JAMA Dermatology, vol. 158, no. 1, pp. 33-42. https://doi.org/10.1001/jamadermatol.2021.4704

@article{4f4e97539c4c4412b22789f8e710163f,

title = "Assessing the potential for patient-led surveillance after treatment of localized melanoma: A pilot randomized controlled trial (the MEL-SELF pilot trial)",

abstract = "Importance Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma.Objective To determine whether patient-led surveillance compared with clinician-led surveillance in patients with prior localized primary cutaneous melanoma is safe, feasible and acceptable.Design Randomized controlled trial.Setting Two specialist-led clinics in metropolitan Sydney and a primary care skin cancer clinic run by general practitioners in metropolitan Newcastle.Participants 100 patients previously treated for localized melanoma, who owned asmartphone, had a partner to assist with skin self-examination (SSE), and were attending routinely scheduled follow-up.Intervention Participants were randomized (1:1) to six months of patient-led surveillance (intervention: usual care plus reminders to perform SSE, patient performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (control: usual care).Main outcomes and measures The primary outcome was the proportion of eligible18 and contacted patients who were randomized. Secondary outcomes includedpatient-reported outcomes (SSE knowledge, attitudes and practice, psychological outcomes, other healthcare use) and clinical outcomes (clinic visits, skin surgeries, subsequent new primary or recurrent melanoma).Results Between November 2018 and May 2019, 326 patients were found to beeligible and contacted, and 100 (31%; 95%CI:26% to 36%) were randomized to patient-led surveillance (n=49) or clinician-led surveillance (n=51). Data were available on patient-reported outcomes for 66 participants, and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance increased SSE frequency and thoroughness, had no detectable effect on psychological outcomes, but did increase clinic visits, skin lesion excisions, and subsequent new primary melanoma diagnoses. New primary melanomas and one local recurrence were diagnosed in 8 intervention group participants (16%) including 5 at unscheduled visits (10%), and 3 control group participants (6%), with none at unscheduled visits (0%) (between-group difference: 10%; 95%CI: 2% to 19%).Conclusion Patient-led surveillance following treatment of localized melanoma appears safe, feasible and acceptable. Difficulties that some participants experienced with adherence, response to questionnaires, and retention in the trial, as well the potential of the intervention to cause medical overuse, have prompted changes to trial processes for a larger trial of the same intervention.",

author = "Ackermann, {Deonna M.} and Mbathio Dieng and Ellie Medcalf and {van Kemenade}, {Cathelijne H.} and Jenkins, {Marisa C} and Monika Janda and Turner, {Robin M.} and Cust, {Anne E.} and Morton, {Rachael L.} and Morton, {Rachael L.} and Les Irwig and Les Irwig and Pascale Guitera and Soyer, {H. Peter} and Victoria Mar and Hersch, {Jolyn K.} and Donald Low and Cynthia Low and Saw, {Robyn P.M.} and Scolyer, {Richard A.} and Dorothy Drabarek and David Espinoza and Anthony Azzi and Alister Lilleyman and Smit, {Amelia K.} and Peter Murchie and Thompson, {John F.} and Bell, {Katy J.L.}",

note = "JFT is a recipient of an NHMRC Program Grant (1093017). RPMS is supported by Melanoma Institute Australia. RAS is supported by an 408 NHMRC Practitioner Fellowship Grant (1141295). Support from colleagues at Melanoma Institute Australia and Royal Prince Alfred Hospital is also gratefully acknowledged. RLM is supported with an NHMRC Investigator grant (1194703). HPS holds NHMRC grants (1062935, 1099021,1137127) MJa was supported by an NHMRC TRIP Fellowship 2018-20 (1151021). JH is supported by an NHMRC Early Career Fellowship (1112509). KLJB is supported by an NHMRC Investigator Grant 21(1174523), The MELSELF pilot RCT was funded through a NHMRC Project grant (1163054), a NHMRC Program grant (402764), and Friends of Mater Research Foundation (2016, 2017) grants. ",

year = "2022",

month = jan,

day = "1",

doi = "10.1001/jamadermatol.2021.4704",

language = "English",

volume = "158",

pages = "33--42",

journal = "JAMA Dermatology",

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TY - JOUR

T1 - Assessing the potential for patient-led surveillance after treatment of localized melanoma

T2 - A pilot randomized controlled trial (the MEL-SELF pilot trial)

AU - Ackermann, Deonna M.

AU - Dieng, Mbathio

AU - Medcalf, Ellie

AU - van Kemenade, Cathelijne H.

AU - Jenkins, Marisa C

AU - Janda, Monika

AU - Turner, Robin M.

AU - Cust, Anne E.

AU - Morton, Rachael L.

AU - Irwig, Les

AU - Guitera, Pascale

AU - Soyer, H. Peter

AU - Mar, Victoria

AU - Hersch, Jolyn K.

AU - Low, Donald

AU - Low, Cynthia

AU - Saw, Robyn P.M.

AU - Scolyer, Richard A.

AU - Drabarek, Dorothy

AU - Espinoza, David

AU - Azzi, Anthony

AU - Lilleyman, Alister

AU - Smit, Amelia K.

AU - Murchie, Peter

AU - Thompson, John F.

AU - Bell, Katy J.L.

N1 - JFT is a recipient of an NHMRC Program Grant (1093017). RPMS is supported by Melanoma Institute Australia. RAS is supported by an 408 NHMRC Practitioner Fellowship Grant (1141295). Support from colleagues at Melanoma Institute Australia and Royal Prince Alfred Hospital is also gratefully acknowledged. RLM is supported with an NHMRC Investigator grant (1194703). HPS holds NHMRC grants (1062935, 1099021,1137127) MJa was supported by an NHMRC TRIP Fellowship 2018-20 (1151021). JH is supported by an NHMRC Early Career Fellowship (1112509). KLJB is supported by an NHMRC Investigator Grant 21(1174523), The MELSELF pilot RCT was funded through a NHMRC Project grant (1163054), a NHMRC Program grant (402764), and Friends of Mater Research Foundation (2016, 2017) grants.

PY - 2022/1/1

Y1 - 2022/1/1

N2 - Importance Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma.Objective To determine whether patient-led surveillance compared with clinician-led surveillance in patients with prior localized primary cutaneous melanoma is safe, feasible and acceptable.Design Randomized controlled trial.Setting Two specialist-led clinics in metropolitan Sydney and a primary care skin cancer clinic run by general practitioners in metropolitan Newcastle.Participants 100 patients previously treated for localized melanoma, who owned asmartphone, had a partner to assist with skin self-examination (SSE), and were attending routinely scheduled follow-up.Intervention Participants were randomized (1:1) to six months of patient-led surveillance (intervention: usual care plus reminders to perform SSE, patient performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (control: usual care).Main outcomes and measures The primary outcome was the proportion of eligible18 and contacted patients who were randomized. Secondary outcomes includedpatient-reported outcomes (SSE knowledge, attitudes and practice, psychological outcomes, other healthcare use) and clinical outcomes (clinic visits, skin surgeries, subsequent new primary or recurrent melanoma).Results Between November 2018 and May 2019, 326 patients were found to beeligible and contacted, and 100 (31%; 95%CI:26% to 36%) were randomized to patient-led surveillance (n=49) or clinician-led surveillance (n=51). Data were available on patient-reported outcomes for 66 participants, and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance increased SSE frequency and thoroughness, had no detectable effect on psychological outcomes, but did increase clinic visits, skin lesion excisions, and subsequent new primary melanoma diagnoses. New primary melanomas and one local recurrence were diagnosed in 8 intervention group participants (16%) including 5 at unscheduled visits (10%), and 3 control group participants (6%), with none at unscheduled visits (0%) (between-group difference: 10%; 95%CI: 2% to 19%).Conclusion Patient-led surveillance following treatment of localized melanoma appears safe, feasible and acceptable. Difficulties that some participants experienced with adherence, response to questionnaires, and retention in the trial, as well the potential of the intervention to cause medical overuse, have prompted changes to trial processes for a larger trial of the same intervention.

AB - Importance Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma.Objective To determine whether patient-led surveillance compared with clinician-led surveillance in patients with prior localized primary cutaneous melanoma is safe, feasible and acceptable.Design Randomized controlled trial.Setting Two specialist-led clinics in metropolitan Sydney and a primary care skin cancer clinic run by general practitioners in metropolitan Newcastle.Participants 100 patients previously treated for localized melanoma, who owned asmartphone, had a partner to assist with skin self-examination (SSE), and were attending routinely scheduled follow-up.Intervention Participants were randomized (1:1) to six months of patient-led surveillance (intervention: usual care plus reminders to perform SSE, patient performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (control: usual care).Main outcomes and measures The primary outcome was the proportion of eligible18 and contacted patients who were randomized. Secondary outcomes includedpatient-reported outcomes (SSE knowledge, attitudes and practice, psychological outcomes, other healthcare use) and clinical outcomes (clinic visits, skin surgeries, subsequent new primary or recurrent melanoma).Results Between November 2018 and May 2019, 326 patients were found to beeligible and contacted, and 100 (31%; 95%CI:26% to 36%) were randomized to patient-led surveillance (n=49) or clinician-led surveillance (n=51). Data were available on patient-reported outcomes for 66 participants, and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance increased SSE frequency and thoroughness, had no detectable effect on psychological outcomes, but did increase clinic visits, skin lesion excisions, and subsequent new primary melanoma diagnoses. New primary melanomas and one local recurrence were diagnosed in 8 intervention group participants (16%) including 5 at unscheduled visits (10%), and 3 control group participants (6%), with none at unscheduled visits (0%) (between-group difference: 10%; 95%CI: 2% to 19%).Conclusion Patient-led surveillance following treatment of localized melanoma appears safe, feasible and acceptable. Difficulties that some participants experienced with adherence, response to questionnaires, and retention in the trial, as well the potential of the intervention to cause medical overuse, have prompted changes to trial processes for a larger trial of the same intervention.

U2 - 10.1001/jamadermatol.2021.4704

DO - 10.1001/jamadermatol.2021.4704

M3 - Article

C2 - 34817543

SN - 2168-6068

VL - 158

SP - 33

EP - 42

JO - JAMA Dermatology

JF - JAMA Dermatology

IS - 1

ER -

Assessing the potential for patient-led surveillance after treatment of localized melanoma: A pilot randomized controlled trial (the MEL-SELF pilot trial)

Abstract

Bibliographical note

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