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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569657
• Other study ID #: 1203830-2
• Status: Completed
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: January 28, 2019

Study information

• Verified date: December 2023
• Source: University of Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 28, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• A positive psychology workshop
Group workshop

Locations

Country	Name	City	State
United States	Rocky Mountain Cancer Centers	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Denver	Rocky Mountain Cancer Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Fatigue	Multidimensional Fatigue Syndrome Inventory-Short Form (Stein, Jacobsen, Blanchard, & Thors, 2004). Score by summing individual subscales (General and Vigo subscales), ranging from 0 to 48. Higher scores indicate greater levels of fatigue.; General scale = sum of items 10, 12, 14, 17, 18, and 28; Vigor scale = sum of items 5, 7, 9, 22, 24, and 29	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)
Other	Change in Loneliness	Three-Item Loneliness Scale (Hughes, Waite, Hawkley, & Cacioppo, 2008). Scores are summed to totaling all of the items, with a possible range from 0-9. Higher scores indicate higher levels of loneliness.	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)
Other	Change in Healthcare utilization	Self-created questions asking how many times in the past week have you sought medical care that was not prescheduled. Items are not scored, and information is only being collected for background data.	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)
Other	Changes in Gratitude	Gratitude Questionnaire-Six Item Form (McCullough, Emmons, & Tsang, 2002). To score, add up your scores for items 1, 2, 4, and 5. Add the reversed scores for items 3 and 6 to the total from Step 1. This is your total GQ-6 score. This number should be between 6 and 42. Higher scores indicate higher levels of gratitude.	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)
Other	Change in Mindfulness	State Mindfulness Scale (Tanay & Bernstein, 2013). Scores are totaled by summing all items, ranging from 21-105. Higher scores indicate higher levels of state mindfulness.	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)
Other	Change in Self-Compassion	Self-Compassion Scale-Short Form (Neff, 2003). A total self-compassion score is computed by reversing the negative subscale items and then adding all subscale scores. Scores can range from 12-60, with higher scores indicating greater levels of self-compassion.	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)
Other	Change in Pain	Brief Pain Inventory (Daut, Cleeland, & Flanery, 1983). Scores are summed to totaling all of the items, with a possible range from 0-50. Higher scores indicate more pain.	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)
Other	Change in Meaning in Life	Meaning in Life Questionnaire (Steger, Frazier, Oishi, & Kaler, 2006). Two subscales are totaled, one for the presence of life meaning (ranging from 0-35, higher levels indicate higher levels of life meaning) and one for the search for life meaning (ranging from 0-35, with higher levels indicating greater efforts directed at searching for life meaning).	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)
Primary	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	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)