The University of Hong Kong
Hong Kong
NCT Number: NCT07836075
The goal of this feasibility study is to learn if a brief meaning-making wellness intervention based on Viktor Frankl's Existential Psychology works to improve fatigue levels in Young Adult Cancer Survivors (YACS) who have completed primary treatment. The main questions it aims to answer are:
* What would be the recruitment and retention rates? * What might the feedback from participants be? * Could there be any effects on fatigue and other related symptoms? Researchers will compare meaning-making to usual care (no intervention) to see if meaning-making works to improve fatigue and other symptoms in YACS.
Participants will:
* Complete questionnaires (self-reported outcome measures) at baseline, 1-week post-intervention, and at 1-month follow-up. * Attend an in-person, two-session brief meaning-making program
Trial opening soon.
Get Notified18 year–39 year
All sexes
Interventional
Not applicable
Hong Kong
Background:
Young Adult Cancer Survivors (YACS) refers to young adults aged 18-39 with a history of cancer, with "survivor" status defined as having completed primary treatment for cancer. YACS encompasses both survivors of Adolescent and Young Adult (AYA) cancer (defined as primary cancer onset at age of 15-39) and childhood cancer (defined as primary cancer onset at age of 0-14). According to statistics from the Hong Kong Cancer Registry, there were 1,471 new cases of AYA cancer and 111 cases of childhood cancer in 2023.
Studies have found fatigue to be prevalent and particularly distressing among Young Adult Cancer Survivors (YACS): 1 in every 4 YACS continued to experience persistent chronic fatigue even after a median of 14 years since cancer diagnosis.
In this connection, we propose a brief meaning-making education program, grounded in Viktor Frankl's Existential Psychology, for facilitating fatigue management in post-treatment Young Adult Cancer Survivors.
Methods:
Participants will be randomly assigned to intervention (2-session, in-person meaning-making education) or control (usual care) at a 1:1 ratio. This study is designed as open label since both interventionist and participants could not be blinded to meaning-making nature of the intervention versus control (no intervention). To prevent contamination, participants in the intervention arm will be advised to avoid discussing the intervention content with others.
Intervention development process will be guided by a Faculty Member of the Viktor Frankl Institute of Logotherapy. Intervention will be delivered by a University lecturer upon completion of 105 hours of training as part of a certificate program at the Viktor Frankl Institute of Logotherapy. Throughout the study period, the interventionist will receive ongoing supervision from a locally registered counselling psychologist in Hong Kong.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remark: Some inclusion and exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
The proposed intervention will be an in-person, group-based, meaning-making wellness programme (two sessions, each 2 to 3-hr long), for Young Adult Cancer Survivors.
Intervention content will be based on core philosophical tenets and concepts of Viktor Frankl's Existential Psychology. Activities include didactic teaching, group discussions, as well as reflective activities through audio-visual media such as visual stories, games, photos, videos and music.
The intervention does not involve psychotherapy.
Intervention development process will be guided by a Faculty Member of the Viktor Frankl Institute of Logotherapy. Intervention will be delivered by a University lecturer upon completion of 105 hours of training as part of a certificate program at the Viktor Frankl Institute of Logotherapy. Throughout the study period, the interventionist will receive ongoing supervision from a locally registered counselling psychologist in Hong Kong.
Time frame: Baseline
The Brief Fatigue Inventory (BFI) is used for assessing Fatigue levels. Scores range from 0 to 10, with higher scores indicating greater severity of Fatigue.
Time frame: 1-week Post-intervention
The Brief Fatigue Inventory (BFI) is used for assessing Fatigue levels. Scores range from 0 to 10, with higher scores indicating greater severity of Fatigue.
Time frame: 1-month Follow-up
The Brief Fatigue Inventory (BFI) is used for assessing Fatigue levels. Scores range from 0 to 10, with higher scores indicating greater severity of Fatigue.
Time frame: Baseline
The Depression subscale of Hospital Anxiety and Depression Scale (HADS-D) is used for assessing Depressive Symptoms. Scores range from 0 to 21, with higher scores indicating greater severity of Depressive Symptoms.
Time frame: 1-week Post-intervention
The Depression subscale of Hospital Anxiety and Depression Scale (HADS-D) is used for assessing Depressive Symptoms. Scores range from 0 to 21, with higher scores indicating greater severity of Depressive Symptoms.
Time frame: 1-month Follow-up
The Depression subscale of Hospital Anxiety and Depression Scale (HADS-D) is used for assessing Depressive Symptoms. Scores range from 0 to 21, with higher scores indicating greater severity of Depressive Symptoms.
Time frame: Baseline
The Anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A) is used for assessing Anxiety Symptoms. Scores range from 0 to 21, with higher scores indicating greater severity of Anxiety Symptoms.
Time frame: 1-week Post-intervention
The Anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A) is used for assessing Anxiety Symptoms. Scores range from 0 to 21, with higher scores indicating greater severity of Anxiety Symptoms.
Time frame: 1-month Follow-up
The Anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A) is used for assessing Anxiety Symptoms. Scores range from 0 to 21, with higher scores indicating greater severity of Anxiety Symptoms.
Time frame: Baseline
The Pittsburgh Sleep Quality Index (PSQI) is used for assessing Sleep Quality. Scores range from 0 to 21, with higher scores indicating poorer Sleep Quality and greater severity of Sleep Disturbances.
Time frame: 1-week Post-intervention
The Pittsburgh Sleep Quality Index (PSQI) is used for assessing Sleep Quality. Scores range from 0 to 21, with higher scores indicating poorer Sleep Quality and greater severity of Sleep Disturbances.
Time frame: 1-week Follow-up
The Pittsburgh Sleep Quality Index (PSQI) is used for assessing Sleep Quality. Scores range from 0 to 21, with higher scores indicating poorer Sleep Quality and greater severity of Sleep Disturbances.
Time frame: Baseline
The Presence of Meaning subscale of Meaning in Life Questionnaire (MLQ-P) is used for assessing the extent to which individuals experience presence of meaning and purpose in their lives. Scores range from 5 to 35, with higher scores indicating higher Presence of Meaning.
Time frame: 1-week Post-intervention
The Presence of Meaning subscale of Meaning in Life Questionnaire (MLQ-P) is used for assessing the extent to which individuals experience presence of meaning and purpose in their lives. Scores range from 5 to 35, with higher scores indicating higher Presence of Meaning.
Time frame: 1-month Follow-up
The Presence of Meaning subscale of Meaning in Life Questionnaire (MLQ-P) is used for assessing the extent to which individuals experience presence of meaning and purpose in their lives. Scores range from 5 to 35, with higher scores indicating higher Presence of Meaning.
Time frame: Baseline
The Search of Meaning subscale of Meaning in Life Questionnaire (MLQ-S) is used for assessing how actively individuals seek meaning and purpose in their lives. Scores range from 5 to 35, with higher scores indicating greater search for meaning.
Time frame: 1-week Post-intervention
The Search of Meaning subscale of Meaning in Life Questionnaire (MLQ-S) is used for assessing how actively individuals seek meaning and purpose in their lives. Scores range from 5 to 35, with higher scores indicating greater search for meaning.
Time frame: 1-month Follow-up
The Search of Meaning subscale of Meaning in Life Questionnaire (MLQ-S) is used for assessing how actively individuals seek meaning and purpose in their lives. Scores range from 5 to 35, with higher scores indicating greater search for meaning.
Time frame: Baseline
The McGill Quality of Life Questionnaire (MQOL) is used for assessing Quality of Life. Scores range from 0 to 10, with higher scores indicating better Quality of Life.
Time frame: 1-week Post-intervention
The McGill Quality of Life Questionnaire (MQOL) is used for assessing Quality of Life. Scores range from 0 to 10, with higher scores indicating better Quality of Life.
Time frame: 1-month Follow-up
The McGill Quality of Life Questionnaire (MQOL) is used for assessing Quality of Life. Scores range from 0 to 10, with higher scores indicating better Quality of Life.
Contact information is provided by the study sponsor or research team.
The University of Hong Kong
Other
Brief Meaning-making Program for Young Adult Cancer Survivors (YACS): An Open-label Randomized Controlled Feasibility Study
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