Clinical trial NCT03569657: Activating Happiness in Cancer: A Positive Psychology Workshop for Patients, Survivors, and Caregivers
Official title: Activating Happiness in Cancer: A Positive Psychology Workshop for Patients, Survivors, and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Caregivers
Lead sponsor: University of Denver
Sponsor class: OTHER
Collaborators: name: Rocky Mountain Cancer Centers
First posted: 2018-06-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Depression
timeFrame: 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:
measure: Change in Anxiety
timeFrame: 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:
measure: Change in Fatigue
timeFrame: 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)
measure: Change in Loneliness
timeFrame: 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)
measure: Change in Healthcare utilization
timeFrame: 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)
measure: Changes in Gratitude
timeFrame: 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)
measure: Change in Mindfulness
timeFrame: 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)
measure: Change in Self-Compassion
timeFrame: 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)
measure: Change in Pain
timeFrame: 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)
measure: Change in Meaning in Life
timeFrame: 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)
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
Study officials:
References: