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Assessing the acceptability, appropriateness, and feasibility of a group therapy program for people with stage III melanoma (MELGROUP): a pilot study

Assessing the acceptability, appropriateness, and feasibility of a group therapy program for people with stage III melanoma (MELGROUP): a pilot study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000815662
Acronym
MELGROUP
Enrollment
32
Registered
2023-07-28
Start date
2023-07-31
Completion date
2025-05-26
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This pilot study is assessing the acceptability, appropriateness, and feasibility of a group therapy program for people with stage III melanoma at Melanoma Institute Australia. Who is it for? You may be eligible for this trial if you are aged over 18 years and have a diagnosis of stage III melanoma. Study details: Group therapy has been helpful to people diagnosed with cancer as it can reduce feelings of isolation that are often experienced following a diagnosis of cancer by increasing social connection to people with similar experiences, while also providing people with tools and strategies to help address difficult emotions or thoughts. Thus, Melanoma Institute Australia have created a new group therapy program for people diagnosed with stage III melanoma, and the aim of this study to ensure it is acceptable and appropriate to participants. There will be a total of 8 sessions that occur every two weeks (fortnightly) either in-person at Melanoma Institute Australia or online via a videoconferencing platform (Zoom). Sessions will be two hours in length and will be focused on discussing skills and strategies that may be helpful in coping with difficult situations/emotions associated with a diagnosis of stage III melanoma. Groups will consist of approximately 8 people recently diagnosed with stage III melanoma. Information from this study will be used to design a larger study to test how helpful it is with the aim or implementing MELGROUP therapy into routine clinical practice in the future.

Interventions

The acceptability, appropriateness, feasibility, and preliminary effectiveness of MELGROUP will be assessed in a single-arm, pilot clinical trial. There will be a total of eight group therapy sessions that occur every two weeks (fortnightly) either in-person at Melanoma Institute Australia or online via a videoconferencing platform (Zoom). Sessions will be two hours in duration and will be focused on discussing skills and strategies that may be helpful in coping with difficult situations/emotio

The acceptability, appropriateness, feasibility, and preliminary effectiveness of MELGROUP will be assessed in a single-arm, pilot clinical trial. There will be a total of eight group therapy sessions that occur every two weeks (fortnightly) either in-person at Melanoma Institute Australia or online via a videoconferencing platform (Zoom). Sessions will be two hours in duration and will be focused on discussing skills and strategies that may be helpful in coping with difficult situations/emotions associated with a diagnosis of stage III melanoma. There will be a maximum of eight participants per group. Psychotherapy groups will be focused on using specific techniques and strategies to allow participants to make changes in their ways of coping with difficult situations/emotions. The psychotherapy group will follow a set manual to provide a combination of psychoeducation and activities that will help participants to understand and incorporate the acceptance and commitment therapy principles into everyday living, and as self-directed tasks for participants to use outside of sessions and following the completion of the group. Take-home tasks might include reflecting on the session or filling out a sheet that asks participants to apply skills they learned in session, like identifying values, and spending some time expanding on and clarifying the values that apply most to themselves. The therapy manual has been developed specifically for this project based on the available evidence for current clinical psychosocial treatments for cancer and the clinical experience of board-approved psychologist co-investigators. The psychotherapy group will also utilise peer support processes to increase the sense of connection between participants and encourage shared reflection, problem-solving and strategies implementation. Once the sessions start, participants will be asked to complete a questionnaire with socio-demographic questions as well as questions about current emotional well-being. At the conclusion of the eight group therapy sessions, participants will be asked to complete a questionnaire about how appropriate and acceptable they found the sessions and about current emotional well-being. One month after the conclusion of the eight group therapy sessions, participants will be asked to complete one final questionnaire about current emotional well-being to see how helpful the sessions have been in helping them cope with stage III melanoma diagnosis. It is anticipated that completing the questionnaires at the start of the sessions, immediately after the final session, and one month following the conclusion of sessions should take no longer than 2 hours of participants’ time altogether. The program will be co-facilitated by two clinical psychologists per group, according to the information provided in the therapy manual. Attendance at sessions will be noted to monitor adherence to the intervention. Both clinical psychologists have clinical experience in treating psycho-social issues in people diagnosed with cancer and melanoma. They have skills in delivering Acceptance and Commitment Therapy interventions, which are evidence-based treatment approaches for managing distress in cancer. Both clinical psychologists have experience in delivering therapeutic group programs.

Sponsors

Melanoma Institute Australia
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

People with histologically confirmed stage III melanoma, who: • Were recently diagnosed with stage III melanoma (within the previous 6 months). • Are proficient in English. • Are 18 years or older at the time of study enrolment. • Are able to attend 8 fortnightly online or in-person group psychotherapy sessions. • Have consented to be part of the MIA’s Melanoma Research Database, which indicated willingness to be contacted for research purposes. • Provide written informed consent.

Exclusion criteria

• People diagnosed with stage 0, I, II, IV, metastatic ocular, mucosal, or other non-cutaneous forms of melanoma. • People with a medically diagnosed psychiatric or cognitive conditions which can interfere with the ability to meet project’s requirements or provide informed consent. • People with a previous or current diagnosis of a different (non-melanoma) cancer.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026