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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
What is being tested?
Behavioral Intervention and Questionnaire Administration
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

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

Other trials in United States

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:

  1. 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.

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 groups in NCT03319342
Study groupRoleWhat they receive
Group I (acts of kindness to others)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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 comparatorParticipants 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted24 Oct 2017
  2. Study start11 Jul 2017
  3. Primary completion3 Dec 2019
  4. Study completion3 Dec 2019

Resources

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)
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

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