Activating Happiness in Cancer: A Positive Psychology Workshop for Patients, Survivors, and Caregivers

Study Overview
=================
Brief Summary
-----------------
The number of worldwide cancer survivors is projected to be 21.3 million by 2030. To treat this growing population, group psychological interventions are increasingly utilized and require empirical support to evaluate their effectiveness. To address the need to assess positive group psychological interventions for cancer survivors and caregivers that incorporates diverse conceptualizations of adaption and examines both mental and physical health outcomes, this project is a study on a 4-week psychoeducation intervention group entitled Activating happiness in cancer: A positive psychology workshop for patients, survivors, and caregivers. The project will evaluate the following hypotheses: (1) Participation in a positive psychology workshop will predict higher levels of well-being, mindfulness, gratitude, and vitality for cancer survivors and caregivers at the end of the group, and these changes will be maintained 3 months after the group has ended; and (2) Participation in a positive psychology intervention group will predict lower levels of depression, anxiety, pain, fatigue, loneliness, and healthcare utilization for cancer survivors and caregivers at the end of the group, and these changes will be maintained 3 months after the group has ended. Additionally, the project poses the following question: (1) What elements of positive psychological workshop do cancer survivors and caregivers perceive as most meaningful?

Detailed Description
-----------------
The number of worldwide cancer survivors is projected to be 21.3 million by 2030. To treat this growing population, group psychological interventions are increasingly utilized and require empirical support to evaluate their effectiveness. Commonly reported psychosocial challenges that individuals face after a cancer diagnosis include depression, anxiety, pain, fatigue, and isolation. In contrast, some cancer survivors have reported increases in their sense of meaning, spirituality, and perceptions of personal growth after cancer. To address the range of responses to cancer, there is a need for strengths-based group interventions that optimize cancer survivors' psychosocial response to cancer, regardless of their distress level. It is critical for these approaches to account for normative periods of distress and despair for many cancer survivors, even as part of positive adaptation, and to honor diversity in human response to cancer. Cancer caregivers have reported similar clusters of symptoms as cancer survivors that often go untreated, in part due to the demands of caregiving responsibilities. Thus, cancer holds the potential to affect not only the patient, but also those closest in their social support network. Positive psychological interventions have demonstrated significant effects for increasing cancer survivors' self-esteem, optimism, self-efficacy, meaning making, and lowering levels of depression, anxiety, and fatigue. Yet no studies have examined the impact of positive psychological interventions on healthcare utilization, pain, loneliness, vitality, and self-compassion for cancer survivors, caregivers, and on the interactions between the well-being of cancer survivors and caregivers. To address the need to assess positive group psychological interventions for cancer survivors and caregivers that incorporates diverse conceptualizations of adaption and examines both mental and physical health outcomes, this project is a study on a 4-week psychoeducation group intervention entitled Activating happiness in cancer: A positive psychology workshop for patients, survivors, and caregivers. The project will evaluate the following hypotheses: (1) Participation in a positive psychology workshop will predict higher levels of well-being, mindfulness, gratitude, and vitality for cancer survivors and caregivers at the end of the group, and these changes will be maintained 3 months after the group has ended; and (2) Participation in a positive psychology workshop will predict lower levels of depression, anxiety, pain, fatigue, loneliness, and healthcare utilization for cancer survivors and caregivers at the end of the group, and these changes will be maintained 3 months after the group has ended. Additionally, the project poses the following question: (1) What elements of positive psychological workshop do cancer survivors and caregivers perceive as most meaningful? This intervention involves assigning participants to the group to evaluate its effectiveness on psychological and healthcare utilization outcomes. The group is not part of routine medical care.

Official Title
-----------------
Activating Happiness in Cancer: A Positive Psychology Workshop for Patients, Survivors, and Caregivers

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: A positive psychology workshop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above the age of 18 either has received a cancer diagnosis OR is the caregiver of someone with a cancer diagnosis Exclusion Criteria: Under the age 18 Does not speak English Has not received a cancer diagnosis nor is the caregiver of someone with a cancer diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Participants are assigned to the group intervention, which is not part of routine medical care, to evaluate the group's effectiveness on participants' psychological well-being and their healthcare utilization.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A positive psychology workshop<br>The group intervention implements a manualized treatment protocol outlining the content of each of the four 90 minute sessions. The sessions will include topics such as mindfulness, self-compassion, gratitude and forgiveness, grief and growth, utilizing one's strengths, and resilience; with each session including homework exercises to be practiced between sessions. To assess the outcome measures, participants complete a baseline survey, a survey after the second session (2 weeks), a survey after the final session (4 weeks), and a follow-up survey 3 months after the workshop has ended (4 months). | Behavioral: A positive psychology workshop<br>* Group workshop<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression | Personal Health Questionnaire Depression Scale (Kroenke et al., 2009). A total PHQ-8 score of 10 or greater in the clinical setting should prompt a careful interview for a number of reasons: to determine if the elevated score represents clinical depression, to consider confounding medical causes, to evaluate for affective disorders that may warrant either more conservative initial treatment than major depression (e.g., minor depression or bereavement) or earlier mental health referral (e.g., bipolar disorder or comorbid substance abuse), and to avoid premature labeling of a person as having depression. | Change from baseline to after 2nd session (2 weeks), baseline to after final session (4 weeks), baseline to after 3 months after final session (up to 16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety | Generalized Anxiety and Depression (Spitzer, Kroenke, Williams, & Lowe, 2006). Scores are summed to get the total score, which can range from 0-21. Anxiety Severity Level: Minimal: 0-4 Mild: 5-9 Moderate: 10-14 Severe: 15-21 | Change from baseline to after 2nd session (2 weeks), baseline to after final session (4 weeks), baseline to after 3 months after final session (up to 16 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caregivers