CancerNCT03569657
Activating Happiness in Cancer: A Positive Psychology Workshop for Patients, Survivors, and Caregivers
A study testing A positive psychology workshop in people with Cancer, run by University of Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- A positive psychology workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2018to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above the age of 18
- either has received a cancer diagnosis OR
- is the caregiver of someone with a cancer diagnosis
Who cannot join
- Under the age 18
- Does not speak English
- Has not received a cancer diagnosis nor is the caregiver of someone with a cancer diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Cancer Centers
Denver, Colorado, 80111
About this study
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?
Read the 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.
- Conditions
- Cancer
- Being tested
- A positive psychology workshop
- Keywords
- Caregivers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A positive psychology workshopBehavioural
Group workshop
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: A positive psychology workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start6 Jun 2018
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Rocky Mountain Cancer Centers
- Responsible party
- Principal investigator, Trisha Raque-Bogdan, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569657
- Sponsor's protocol ID
- 1203830-2
- Status last verified
- Dec 2023
- First submitted
- 30 May 2018
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Happiness in Cancer: A Positive Psychology Workshop for Patients, Survivors, and Caregivers
- ClinicalTrials.gov ID
- NCT03569657
- Acronym / sponsor ID
- 1203830-2
- Conditions
- Cancer
- Keywords
- Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Collaborators
- Rocky Mountain Cancer Centers
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| A positive psychology workshop | Other | Behavioral: A positive psychology workshopThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above the age of 18
- either has received a cancer diagnosis OR
- is the caregiver of someone with a cancer diagnosis
Key exclusion criteria (3 listed)
- Under the age 18
- Does not speak English
- Has not received a cancer diagnosis nor is the caregiver of someone with a cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A positive psychology workshopGroup workshop | Behavioural | A positive psychology workshop |
Primary outcome
Change in Depression
Time frame: 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)
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."
1 secondary outcome
Change in Anxiety
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A positive psychology workshop in people with Cancer, run by University of Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.