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

NCT03569657 | Completed

• 1 other identifier: 1203830-2
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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?

Conditions

Cancer

Keywords

Caregivers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Anxiety

  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 Outcomes (8)

• Change in Fatigue

  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)

• Change in 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)

• Change in Healthcare utilization

  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)

Study Arms (1)

A positive psychology workshop

OTHER

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

Interventions

A positive psychology workshop BEHAVIORAL

Group workshop

A positive psychology workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above the age of 18
• either has received a cancer diagnosis OR
• is the caregiver of someone with a cancer diagnosis

You may not qualify if:

• Under the age 18
• Does not speak English
• Has not received a cancer diagnosis nor is the caregiver of someone with a cancer diagnosis

Sponsors & Collaborators

• University of Denver: lead
• Rocky Mountain Cancer Centers: collaborator

Study Sites (1)

Rocky Mountain Cancer Centers

Denver, Colorado, 80111, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 26, 2018
• Study Start: June 6, 2018
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)