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Trial registered on ANZCTR


Registration number
ACTRN12623000815662
Ethics application status
Approved
Date submitted
7/07/2023
Date registered
28/07/2023
Date last updated
28/07/2023
Date data sharing statement initially provided
28/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the acceptability, appropriateness, and feasibility of a group therapy program for people with stage III melanoma (MELGROUP): a pilot study
Scientific title
Assessing the acceptability, appropriateness, and feasibility of a group therapy program for people with stage III melanoma (MELGROUP): a pilot study
Secondary ID [1] 309923 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MELGROUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage III Melanoma 330401 0
Condition category
Condition code
Cancer 327241 327241 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326390 0
Treatment: Other
Intervention code [2] 326391 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335181 0
Acceptability of the intervention will be assessed using the Acceptability of Intervention Measure (AIM) survey.
Timepoint [1] 335181 0
Post-intervention (within a week of the completed final session)
Primary outcome [2] 335182 0
The first feasibility measure (assessed as the percentage of eligible participants who complete the program, assessed as attendance at 6/8 of the sessions) will be collected from an audit of session attendance records.
Timepoint [2] 335182 0
Post-intervention (within a week of the completed final session)
Primary outcome [3] 335183 0
Reasons provided by patients for declining or withdrawing participation, and for any missed group therapy sessions. Participants will be asked to share any reasons they have for their withdrawal of participation over a telephone conversation and responses will be recorded by the investigator
Timepoint [3] 335183 0
At any time during intervention or follow-up period
Secondary outcome [1] 423410 0
Participant distress will be assessed using the NCCN Distress Thermometer (DT)
Timepoint [1] 423410 0
Baseline, post-intervention (within a week of the completed final session), 1 month post-intervention
Secondary outcome [2] 423411 0
Participant Well-being will be assessed using the 7-item Short Warwick-Edinburgh Mental Well-being scale (SWEMWBS)
Timepoint [2] 423411 0
Baseline, post-intervention (within a week of the completed final session), 1 month post-intervention
Secondary outcome [3] 423412 0
Participant social connectedness will be assessed using the 10-item Appraisal subscale of the Interpersonal Support Evaluation List (ISEL)
Timepoint [3] 423412 0
Baseline, post-intervention (within a week of the completed final session), 1 month post-intervention
Secondary outcome [4] 424354 0
Participant distress will be assessed using the NCCN Problem list.
Timepoint [4] 424354 0
Baseline, post-intervention (within a week of the completed final session), 1 month post-intervention
Secondary outcome [5] 424357 0
A second measure of feasibility (assessed as the percentage of eligible participants who provide informed consent) will be measured by auditing the study enrolment logs.
Timepoint [5] 424357 0
Post-intervention (within a week of the completed final session)
Secondary outcome [6] 424358 0
A third measure of feasibility (assessed as the percentage of eligible participants who complete at least one session) will be measured by auditing the study enrolment logs.
Timepoint [6] 424358 0
Post-intervention (within a week of the completed final session)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
A total of 32 participants will be recruited from Melanoma Institute Australia. The sample size for this pilot study is based on available resources. No power analysis is required because the primary purpose is to assess acceptability, feasibility, and appropriateness of the group psychotherapy treatment, rather than effectiveness.

Demographic information will be collected and summarised with descriptive statistics including the mean and standard deviation for continuous data and percentages for categorical data.
Acceptability, appropriateness, and feasibility surveys and process data will be summarised with descriptive statistics including mean change over time and standard deviation. This data will be analysed separately for online and in-person groups to see whether there are any differences in the acceptability / feasibility, which will inform any decisions regarding which group to offer as a part of larger RCT.

Open-ended qualitative questions will be analysed using thematic analysis.

The participant-reported effectiveness outcomes will be summarised with descriptive statistics. Psychological distress, mental-well-being, and social connectedness will be measured by considering the percentage of participants above and below the cut-off scores at the different measurement time points. Psychological wellbeing, and social connectedness will be summarised using descriptive statistics, including the mean and standard deviation scores.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
Date of last participant enrolment
Anticipated
26/05/2025
Actual
Date of last data collection
Anticipated
27/10/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24980 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 40633 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 314105 0
Commercial sector/Industry
Name [1] 314105 0
Bristol Myers Squibb
Country [1] 314105 0
Australia
Primary sponsor type
Other
Name
Melanoma Institute Australia
Address
40 Rocklands Road Wollstonecraft NSW 2067
Country
Australia
Secondary sponsor category [1] 316022 0
None
Name [1] 316022 0
Address [1] 316022 0
Country [1] 316022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313245 0
Sydney Local Health District - Royal Prince Alfred zone
Ethics committee address [1] 313245 0
Ethics committee country [1] 313245 0
Australia
Date submitted for ethics approval [1] 313245 0
05/06/2023
Approval date [1] 313245 0
19/06/2023
Ethics approval number [1] 313245 0
Protocol no. X23-0107 & 2023/ETH00561

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127462 0
Dr Iris Bartula
Address 127462 0
Melanoma Institute Australia Poche Centre 40 Rocklands Road Wollstonecraft NSW 2065
Country 127462 0
Australia
Phone 127462 0
+61 02 9911 7398
Fax 127462 0
Email 127462 0
iris.bartula@melanoma.org.au
Contact person for public queries
Name 127463 0
Iris Bartula
Address 127463 0
Melanoma Institute Australia Poche Centre 40 Rocklands Road Wollstonecraft NSW 2065
Country 127463 0
Australia
Phone 127463 0
+61 02 9911 7398
Fax 127463 0
Email 127463 0
iris.bartula@melanoma.org.au
Contact person for scientific queries
Name 127464 0
Iris Bartula
Address 127464 0
Melanoma Institute Australia Poche Centre 40 Rocklands Road Wollstonecraft NSW 2065
Country 127464 0
Australia
Phone 127464 0
+61 02 9911 7398
Fax 127464 0
Email 127464 0
iris.bartula@melanoma.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data will be de-identified using unique patient ID's before analysis. This de-identified data will be made available for sharing, and will include patient baseline, post-treatment, and follow-up questionnaires.
When will data be available (start and end dates)?
De-identified data will be available post-publication of the study results. The de-identified data will be available indefinitely.
Available to whom?
De-identified data will be available to any researchers who submit a methodologically-sound, HREC-approved research approval to use the data to Dr. Bartula, who will consult with the investigator team and release data if deemed appropriate
Available for what types of analyses?
De-identified data will be available to achieve objectives as outlined in the proposal that has been approved by Dr Bartula and investigators.
How or where can data be obtained?
Please contact Dr. Bartula:
Melanoma Institute Australia
Poche Centre
40 Rocklands Road
Wollstonecraft NSW 2065
02 9911 7398
iris.bartula@melanoma.org.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19533Study protocol  iris.bartula@melanoma.org.au
19534Ethical approval  iris.bartula@melanoma.org.au
19535Data dictionary  iris.bartula@melanoma.org.au
19627Other  iris.bartula@melanoma.org.au MELGROUP therapist manual



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.