Cancer, Coping Behavior, Coping Skills
Conditions
Keywords
Cancer, Coping Skills, Coping Behavior
Brief summary
The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors.
Detailed description
This is a randomized pilot feasibility trial (1:1 intervention versus usual care; a referral to community-based cancer survivor support group) that will use mixed methods (quantitative and qualitative) to evaluate the feasibility, acceptability, and preliminary effects of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (IN FOCUS) among cancer survivors with clinically elevated fear of recurrence (N = approximately 64). Patient-reported outcomes on psychological and behavioral outcomes will be measured at T0 (baseline), T1 (post-intervention/approximately two months post-baseline), and T2 (three months post-intervention/approximately five months post-baseline). Exit interviews will be conducted after the T1 survey. Participants are expected to be in the study for approximately five months.
Interventions
BEHAVIORALIN FOCUS
Adapted Resiliency Group Intervention
BEHAVIORALUsual Care
Referral to Virtual Group Support
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of non-metastatic, localized, or regional solid or blood malignancy(ies) * Completion of primary cancer treatment (i.e., radiation, surgery, chemotherapy) and/or current use of long-term maintenance hormonal or biologic therapy * Age ≥18 years * Elevated fear of recurrence (FCRI severity score ≥16) * MGB/BIDMC Medical Record Number (MRN)
Exclusion criteria
* Self-reported inability to speak and write in English * Undertreated serious mental illness as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year * Inability to access technology and/or sufficient internet to participate virtual groups sessions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Retention Rate | Baseline to approximately 2 months | The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions. |
| Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction | Baseline to approximately 2 months | As a primary quantitative acceptability outcome, participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear of Cancer Recurrence | Baseline, approximately 2 months, approximately 5 months | Fear of cancer recurrence (FCR) severity will be measured using the 9-item Fear of Cancer Recurrence Inventory severity subscale. Scores range from 0-36 with higher scores indicating greater FCR severity. To supplement this measure, open-ended questions in the exit interview will assess perceived changes in FCR. |
| Resiliency | Baseline, approximately 2 months, approximately 5 months | Resiliency will be measured using the 23-item Current Experiences Scale. Subscale scores and total scores (range from 0-115) will be computed, with higher scores indicating higher resiliency. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention (IN FOCUS) Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills.
IN FOCUS: Adapted Resiliency Group Intervention | 32 |
| Usual Care Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community.
Usual Care: Referral to Virtual Group Support | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Declined | 2 | 3 |
| Overall Study | Missed | 2 | 0 |
Baseline characteristics
| Characteristic | Intervention (IN FOCUS) | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 51.1 Years STANDARD_DEVIATION 14.7 | 53.7 Years STANDARD_DEVIATION 12.7 | 52.4 Years STANDARD_DEVIATION 13.7 |
| Race/Ethnicity, Customized Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 29 Participants | 30 Participants | 59 Participants |
| Sex: Female, Male Female | 26 Participants | 27 Participants | 53 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
As a primary quantitative acceptability outcome, participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the intervention.
Time frame: Baseline to approximately 2 months
Population: This acceptability metric was assessed within the intervention arm only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IN FOCUS | Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction | Enjoyableness | 4.33 score on a scale | Standard Deviation 0.71 |
| IN FOCUS | Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction | Convenience | 4.57 score on a scale | Standard Deviation 0.82 |
| IN FOCUS | Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction | Helpfulness | 4.00 score on a scale | Standard Deviation 1.02 |
| IN FOCUS | Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction | Odds of Future Skills Use | 4.33 score on a scale | Standard Deviation 1.03 |
| IN FOCUS | Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction | Overall Satisfaction | 4.20 score on a scale | Standard Deviation 0.92 |
Primary
Feasibility: Retention Rate
The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions.
Time frame: Baseline to approximately 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IN FOCUS | Feasibility: Retention Rate | 31 Participants |
| Usual Care | Feasibility: Retention Rate | 31 Participants |
Secondary
Fear of Cancer Recurrence
Fear of cancer recurrence (FCR) severity will be measured using the 9-item Fear of Cancer Recurrence Inventory severity subscale. Scores range from 0-36 with higher scores indicating greater FCR severity. To supplement this measure, open-ended questions in the exit interview will assess perceived changes in FCR.
Time frame: Baseline, approximately 2 months, approximately 5 months
Population: Not all surveys were returned.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IN FOCUS | Fear of Cancer Recurrence | 2 Months | 19.74 score on a scale | Standard Deviation 4.54 |
| IN FOCUS | Fear of Cancer Recurrence | 5 Months | 20.66 score on a scale | Standard Deviation 5.21 |
| IN FOCUS | Fear of Cancer Recurrence | Baseline | 23.62 score on a scale | Standard Deviation 4.19 |
| Usual Care | Fear of Cancer Recurrence | 2 Months | 20.90 score on a scale | Standard Deviation 5.34 |
| Usual Care | Fear of Cancer Recurrence | 5 Months | 19.27 score on a scale | Standard Deviation 6.08 |
| Usual Care | Fear of Cancer Recurrence | Baseline | 22.22 score on a scale | Standard Deviation 4.88 |
Secondary
Resiliency
Resiliency will be measured using the 23-item Current Experiences Scale. Subscale scores and total scores (range from 0-115) will be computed, with higher scores indicating higher resiliency.
Time frame: Baseline, approximately 2 months, approximately 5 months
Population: Not all surveys were returned.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IN FOCUS | Resiliency | Baseline | 71.05 score on a scale | Standard Deviation 14 |
| IN FOCUS | Resiliency | 2 Months | 76.24 score on a scale | Standard Deviation 11.89 |
| IN FOCUS | Resiliency | 5 Months | 81.05 score on a scale | Standard Deviation 11.66 |
| Usual Care | Resiliency | Baseline | 75.23 score on a scale | Standard Deviation 14.05 |
| Usual Care | Resiliency | 2 Months | 76.80 score on a scale | Standard Deviation 15.51 |
| Usual Care | Resiliency | 5 Months | 75.45 score on a scale | Standard Deviation 16.34 |