Cancer SurvivorNCT03319342
Kindness Interventions in Enhancing Well-Being in Breast Cancer Survivors
A study testing Behavioral Intervention and Questionnaire Administration in people with Cancer Survivor and Stage 0 Breast Cancer AJCC v6 and v7, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
Emerging evidence suggests that both extending kindness towards others and self-kindness practices may have beneficial effects on well-being. This randomized pilot clinical trial will investigate the efficacy of two kindness interventions -acts of kindness (to self or to other) and loving-kindness meditation- for use… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Cancer Survivor, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7
- What is being tested?
- Behavioral Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2017to 3 Dec 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women previously diagnosed with stage 0-IIIA breast cancer
- Have completed treatment with surgery, radiation, and/or chemotherapy
- Have not had a cancer recurrence
- Have access to the internet and an active email account
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
University of California-Riverside
Riverside, California, 92521
About this study
Official title: Kindness to Others or to Oneself: A Pilot Randomized Controlled Trial of Kindness Interventions to Enhance Well-Being in Breast Cancer Survivors
Emerging evidence suggests that both extending kindness towards others and self-kindness practices may have beneficial effects on well-being. This randomized pilot clinical trial will investigate the efficacy of two kindness interventions -acts of kindness (to self or to other) and loving-kindness meditation- for use with early-stage breast cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To refine two interventions - loving kindness and acts of kindness- for use with breast cancer survivors using an online platform.
II. To determine the feasibility and preliminary efficacy of these interventions on positive affect, depressive symptoms, and other aspects of well-being among women with breast cancer.
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I (ACTS OF KINDNESS TO OTHERS): Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires.
GROUP II (ACTS OF KINDNESS TO SELF): Participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires.
GROUP III (SELF-KINDNESS MEDITATION): Participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires.
GROUP IV (CONTROL): Participants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. At the end of the week, participants report on their activities and complete several online questionnaires.
- Conditions
- Cancer Survivor, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7
- Being tested
- Behavioral Intervention, Questionnaire Administration
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Perform acts of kindness to others
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Perform acts of kindness to self
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Perform self-kindness meditation
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Keep track of daily activities
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (acts of kindness to others) | Experimental | Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires. Receives: Behavioral: Behavioral Intervention; Other: Questionnaire Administration |
| Group II (acts of kindness to self) | Experimental | Participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires. Receives: Behavioral: Behavioral Intervention; Other: Questionnaire Administration |
| Group III (self-kindness meditation) | Experimental | Participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires. Receives: Behavioral: Behavioral Intervention; Other: Questionnaire Administration |
| Group IV (track daily activities) | Active comparator | Participants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. At the end of the week, participants report on their activities and complete several online questionnaires. Receives: Behavioral: Behavioral Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms (Center for Epidemiologic Studies Depression Scale)
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Depressive symptoms will be measured at baseline and post-intervention using the 20-item Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a measure of symptom severity across the previous week, and total scores range from 0 to 60. Higher scores indicate greater severity of depressive symptoms.
Measured: Up to 2 years
Psychological well-being measured by the Mental Health Continuum-Short Form
Analyses will be conducted under the intent-to-treat principle, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Psychological well-being measured by the Mental Health Continuum-Short Form (MHC-SF) Well-being will be measured at both baseline and post-intervention via the 14-item MHC-SF. Total scores range from 0 to 70, with higher scores indicating greater overall well-being. The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale (score range: 0 to 15), the 6-item Psychological Well-Being Subscale (score range: 0 to 30), and the 5-item Social Well-Being Subscale (score range: 0 to 25). Higher scores on each subscale indicate greater well-being within that domain.
Measured: Up to 2 years
Secondary outcomes (12)
Big-5 Personality Dimensions measured by the Ten-Item Personality Inventory (TIPI)
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Big-5 Personality Dimensions measured by the Ten-Item Personality Inventory (TIPI) measured at baseline: Personality dimensions will be measured at baseline by the 10-item TIPI. There are 5 subscales on the TIPI, each with 2-items: Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to Experience. Scores on each subscale range from 2 to 14, with higher scores indicating greater endorsement of the corresponding personality domain.
Measured: Baseline
Empathy measured by the Perspective Taking & Empathic Concern Subscales of the Interpersonal Reactivity Index
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Empathy measured by the Perspective Taking \& Empathic Concern Subscales of the Interpersonal Reactivity Index: Empathy will be measured pre- and post-intervention using the 6-item Perspective Taking (range: 0 to 30) and 7-item Empathic Concern Subscales (range: 0-35) of the IRI. Higher scores indicate greater characteristics of empathy.
Measured: Up to 2 years
Fatigue measured by the Severity items of the Fatigue Symptom Inventory
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Fatigue measured by the Severity items of the Fatigue Symptom Inventory (FSI): Fatigue will be measured pre- and post-intervention using the 4-item Severity subscale of the FSI. Scores range from 0 to 40, with higher scores indicating greater severity.
Measured: Up to 2 years
Fulfillment of psychological needs measured by the Balanced Measure of Psychological Needs
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Fulfillment of psychological needs measured by the Balanced Measure of Psychological Needs: Fulfillment of psychological needs will be measured weekly using the 9-item Balanced Measure of Psychological Needs. Scores range from 5 to 45, with higher scores indicating greater life satisfaction.
Measured: Up to 2 years
Life satisfaction measured by the Satisfaction with Life Scale
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Life Satisfaction measured by the Satisfaction with Life Scale: Satisfaction with life will be measured pre- and post-intervention using the 5-item Satisfaction With Life Scale. Scores range from 5 to 35, with higher scores indicating greater satisfaction. A score of 31 to 35 represents "extremely satisfied," for example.
Measured: Up to 2 years
Pain measured by the Pain Subscale of the Rand Health 36-item Short Form Survey
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Pain measured by the Pain Subscale of the Rand Health 36-item Short Form Survey (SF-36): Pain severity and interference will be measured pre- and post-intervention using the 2-item pain subscale of the SF-36. Scores range from 0 to 100, with higher scores indicating less severity/interference.
Measured: Up to 2 years
Positive and negative affect measured by the Affect-Adjective Scale
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Positive and negative affect measured by the Affect-Adjective Scale: Positive and negative affect will be measured weekly using the 9-item Affect-Adjective Scale. Three additional adjectives (i.e., embarrassed, uncomfortable, ashamed) were added by the researchers. Scores on the 4-item positive affect subscale range from 0 to 24, with higher scores indicating more positive affect. Scores on the 5-item negative affect subscale range from 0 to 30, with higher scores indicating greater negative affect.
Measured: Up to 2 years
Qualitative assessment of acts performed
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Qualitative assessment of acts performed: At the end of each week, participants will be asked to report on their weekly activities via a free response text box. The content of these activities may be coded or analyzed to provide context to quantitative data.
Measured: Up to 2 years
Self-kindness measured by the Self-Compassion Scale
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Self-kindness measured by the Self-Compassion Scale (SCS): Dispositional self-kindness will be measured pre- and post-intervention using the 5-item Self-Kindness Subscale of the SCS. Total scores on the Self-Kindness Subscale range from 5 to 25, with higher scores indicating greater levels of self-compassion.
Measured: Up to 2 years
Sleep disturbance measured by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Sleep disturbance measured by the PROMIS Sleep Disturbance Scale: Sleep disturbance will be measured pre- and post-intervention using the 4-item PROMIS Sleep Disturbance Scale. Scores range from 4 to 20, with higher scores indicating more disturbance.
Measured: Up to 2 years
Social connection measured by the Attachment Subscale of the Social Provisions Scale
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Social connection measured by the Attachment Subscale of the Social Provisions Scale: Social connection will be measured pre- and post-intervention using the 4-item Attachment subscale of the Social Provisions Scale. Scores range from 4 to 16, with higher scores indicating greater social connection.
Measured: Up to 2 years
Social support measured by the 2-way Social Support Scale
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained.
Social support measured by the 2-way Social Support Scale: Social support will be measured pre- and post-intervention using the 21-item 2-way Social Support Scale. Total scores range from 0 to 105, with higher scores indicating more perceived support.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start11 Jul 2017
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julienne Bower, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319342
- Sponsor's protocol ID
- 17-000560
- Other IDs
- NCI-2017-01469, JCCCID776, 17-000560
- Status last verified
- Dec 2019
- First submitted
- 28 Sep 2017
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kindness to Others or to Oneself: A Pilot Randomized Controlled Trial of Kindness Interventions to Enhance Well-Being in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03319342
- Acronym / sponsor ID
- 17-000560
- Conditions
- Cancer Survivor, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 24 Oct 2017 (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.
Emerging evidence suggests that both extending kindness towards others and self-kindness practices may have beneficial effects on well-being. This randomized pilot clinical trial will investigate the efficacy of two kindness interventions -acts of kindness (to self or to other) and loving-kindness meditation- for use with early-stage breast cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To refine two interventions - loving kindness and acts of kindness- for use with breast cancer survivors using an online platform.
II. To determine the feasibility and preliminary efficacy of these interventions on positive affect, depressive symptoms, and other aspects of well-being among women with breast cancer.
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I (ACTS OF KINDNESS TO OTHERS): Participants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires.
GROUP II (ACTS OF KINDNESS TO SELF): Participants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires.
GROUP III (SELF-KINDNESS MEDITATION): Participants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires.
GROUP IV (CONTROL): Participants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. At the end of the week, participants report on their activities and complete several online questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (acts of kindness to others) | Experimental | Behavioral: Behavioral Intervention, Other: Questionnaire AdministrationParticipants perform small acts of kindness or generosity for others 3 times per week for 4 weeks and complete weekly online questionnaires. |
| Group II (acts of kindness to self) | Experimental | Behavioral: Behavioral Intervention, Other: Questionnaire AdministrationParticipants perform small acts of kindness for themselves 3 times per week for 4 weeks and complete weekly online questionnaires. |
| Group III (self-kindness meditation) | Experimental | Behavioral: Behavioral Intervention, Other: Questionnaire AdministrationParticipants direct kind, loving thoughts to themselves, via guided meditation, 3 times per week for 4 weeks and complete weekly online questionnaires. |
| Group IV (track daily activities) | Active comparator | Behavioral: Behavioral Intervention, Other: Questionnaire AdministrationParticipants keep track of their daily activities, focusing on factual information rather than thoughts and feelings, on 3 separate days each week. At the end of the week, participants report on their activities and complete several online questionnaires. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women previously diagnosed with stage 0-IIIA breast cancer
- Have completed treatment with surgery, radiation, and/or chemotherapy
- Have not had a cancer recurrence
- Have access to the internet and an active email account
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyPerform acts of kindness to others | Behavioural | Group I (acts of kindness to others) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyPerform acts of kindness to self | Behavioural | Group II (acts of kindness to self) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyPerform self-kindness meditation | Behavioural | Group III (self-kindness meditation) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyKeep track of daily activities | Behavioural | Group IV (track daily activities) |
| Questionnaire AdministrationAncillary studies | Other | Group I (acts of kindness to others), Group II (acts of kindness to self), Group III (self-kindness meditation), Group IV (track daily activities) |
Primary outcome
Depressive symptoms (Center for Epidemiologic Studies Depression Scale)
Time frame: Up to 2 years
Analyses will be conducted under the intent-to-treat principle, including all participants in their assigned condition, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Linear mixed models provide valid inferences under a missing at random assumption. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained. Depressive symptoms will be measured at baseline and post-intervention using the 20-item Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a measure of symptom severity across the previous week, and total scores range from 0 to 60. Higher scores indicate greater severity of depressive symptoms.
Psychological well-being measured by the Mental Health Continuum-Short Form
Time frame: Up to 2 years
Analyses will be conducted under the intent-to-treat principle, accomplished by fitting models to all available data for each outcome measure, including data of participants with incomplete follow-up. Analyses will control for any participant characteristics with baseline imbalance among conditions or that differ between participants retained. Psychological well-being measured by the Mental Health Continuum-Short Form (MHC-SF) Well-being will be measured at both baseline and post-intervention via the 14-item MHC-SF. Total scores range from 0 to 70, with higher scores indicating greater overall well-being. The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale (score range: 0 to 15), the 6-item Psychological Well-Being Subscale (score range: 0 to 30), and the 5-item Social Well-Being Subscale (score range: 0 to 25). Higher scores on each subscale indicate greater well-being within that domain.
12 secondary outcomes
Big-5 Personality Dimensions measured by the Ten-Item Personality Inventory (TIPI)
Time frame: Baseline
Empathy measured by the Perspective Taking & Empathic Concern Subscales of the Interpersonal Reactivity Index
Time frame: Up to 2 years
Fatigue measured by the Severity items of the Fatigue Symptom Inventory
Time frame: Up to 2 years
Fulfillment of psychological needs measured by the Balanced Measure of Psychological Needs
Time frame: Up to 2 years
Life satisfaction measured by the Satisfaction with Life Scale
Time frame: Up to 2 years
Pain measured by the Pain Subscale of the Rand Health 36-item Short Form Survey
Time frame: Up to 2 years
Positive and negative affect measured by the Affect-Adjective Scale
Time frame: Up to 2 years
Qualitative assessment of acts performed
Time frame: Up to 2 years
Self-kindness measured by the Self-Compassion Scale
Time frame: Up to 2 years
Sleep disturbance measured by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale
Time frame: Up to 2 years
Social connection measured by the Attachment Subscale of the Social Provisions Scale
Time frame: Up to 2 years
Social support measured by the 2-way Social Support Scale
Time frame: Up to 2 years
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 24 Jul 2020.
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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.
Julienne Bower principal investigator
UCLA / Jonsson Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention and Questionnaire Administration in people with Cancer Survivor and Stage 0 Breast Cancer AJCC v6 and v7, run by Jonsson Comprehensive Cancer Center at 2 sites 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 4 inclusion and 0 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 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Depressive symptoms (Center for Epidemiologic Studies Depression Scale) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 24 Jul 2020.