Cancer, Depression, Anxiety, Survivorship
Conditions
Keywords
Telemental intervention
Brief summary
The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.
Detailed description
Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions. Secondary Objective: To reduce depression and anxiety levels through meaning-making.
Interventions
BEHAVIORALTelemental Health Sessions, Support Groups and Questionnaires
Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Documented cancer diagnosis within the Wake Forest Baptist Medical Center medical record; * Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment); * Aged 18-39 * Must speak English * Must have computer with audio and visual capabilities. * Must live within North Carolina * Must have experienced health-related anxiety and/or distress in last 3 months.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Efficacy in Pandemic Conditions | At baseline up to 8 weeks | The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Depression and Anxiety Levels (CAS) | At baseline up to 8 weeks | Three instruments will provide information on baseline, Visit 8, and change over time. 1\) The Coronavirus Anxiety Scale (CAS) - 5-item mental health screener of dysfunctional anxiety associated with the coronavirus. Scoring is on a 5-point scale of 0 (not at all) to 4 (nearly every day). Minimum score (0): A score of 0 indicates that a person has not experienced any dysfunctional anxiety symptoms related to the coronavirus within the past two weeks. Maximum score (20): A score of 20 indicates the highest level of coronavirus-related anxiety, with the individual experiencing all five symptoms nearly every day over the past two weeks. |
| Changes in Depression and Anxiety Levels (PIL) | At baseline up to 8 weeks | Three instruments will provide information on baseline, Visit 8, and change over time. 2\) The Purpose in Life Test (PIL) - 20-item, 7-point Likert scale designed to measure the extent to which a respondent perceives a general sense of meaning and purpose in life using varying scale labels, scores are aggregated with a minimum score of 20 (lowest purpose) and a maximum score of 140 (highest purpose). |
| Changes in Depression and Anxiety Levels (MAC) | At baseline up to 8 weeks | Three instruments will provide information on baseline, Visit 8, and change over time. 3\) Mini-Mental Adjustments to Cancer - 29-item, 4-point Likert scale (maximum possible score of 116 and minimum possible score of 29) for rapid assessment of present coping style from 1 (Definitely Does Not Apply to Me) to 4 (Definitely Apply to Me), higher score represents higher endorsement of the adjustment response. (4). Five subscales include: Helpless-Hopeless (score range 8-32), Anxious Preoccupation (score range 8-32), Cognitive Avoidance (score range 4-16), Fighting Spirit (score range 4-16) and Fatalism (score range 5-20). |
Countries
United States
Participant flow
Recruitment details
Among the eligible recruitment pool, direct staff member referrals were most common. The final group was comprised primarily of referrals from existing databases.
Pre-assignment details
The most common exclusion reasons were being from outside the health system, patients/missing information or deceased prior to medical record review and non-North Carolina resident status. 55 individuals met basic study criteria, 42% cited no specific reason for declining interest or participation. 14 individuals (25%) were both eligible and interested in participating. Two people consented but did not participate. Four individuals never formally consented.
Participants by arm
| Arm | Count |
|---|---|
| TeleHealth Group The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.
Telemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | TeleHealth Group |
|---|---|
| Age, Continuous | 26 years |
| Marital Status Divorced | 1 Participants |
| Marital Status Married | 1 Participants |
| Marital Status Single | 5 Participants |
| Marital Status Widowed | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
| Work/Study Location Home | 6 Participants |
| Work/Study Location Office or School | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change in Self-Efficacy in Pandemic Conditions
The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy.
Time frame: At baseline up to 8 weeks
Population: Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TeleHealth Group | Change in Self-Efficacy in Pandemic Conditions | Baseline | 86.7 score on a scale |
| TeleHealth Group | Change in Self-Efficacy in Pandemic Conditions | 4 weeks | 87.0 score on a scale |
| TeleHealth Group | Change in Self-Efficacy in Pandemic Conditions | 8 weeks | 87.8 score on a scale |
Comparison: To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. All statistical test used an alpha of 0.05.p-value: 0.803695% CI: [-7.3, 9]t-test, 2 sided
Secondary
Changes in Depression and Anxiety Levels (CAS)
Three instruments will provide information on baseline, Visit 8, and change over time. 1\) The Coronavirus Anxiety Scale (CAS) - 5-item mental health screener of dysfunctional anxiety associated with the coronavirus. Scoring is on a 5-point scale of 0 (not at all) to 4 (nearly every day). Minimum score (0): A score of 0 indicates that a person has not experienced any dysfunctional anxiety symptoms related to the coronavirus within the past two weeks. Maximum score (20): A score of 20 indicates the highest level of coronavirus-related anxiety, with the individual experiencing all five symptoms nearly every day over the past two weeks.
Time frame: At baseline up to 8 weeks
Population: Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TeleHealth Group | Changes in Depression and Anxiety Levels (CAS) | Baseline | 1.0 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (CAS) | 4 weeks | 0.8 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (CAS) | 8 weeks | 0.2 score on a scale |
p-value: 0.363295% CI: [-0.6, 0.3]t-test, 2 sided
Secondary
Changes in Depression and Anxiety Levels (MAC)
Three instruments will provide information on baseline, Visit 8, and change over time. 3\) Mini-Mental Adjustments to Cancer - 29-item, 4-point Likert scale (maximum possible score of 116 and minimum possible score of 29) for rapid assessment of present coping style from 1 (Definitely Does Not Apply to Me) to 4 (Definitely Apply to Me), higher score represents higher endorsement of the adjustment response. (4). Five subscales include: Helpless-Hopeless (score range 8-32), Anxious Preoccupation (score range 8-32), Cognitive Avoidance (score range 4-16), Fighting Spirit (score range 4-16) and Fatalism (score range 5-20).
Time frame: At baseline up to 8 weeks
Population: Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 4 weeks -Helplessness/hopelessness | 11.5 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 8 weeks- Fatalism | 15.8 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | Baseline-Anxious preoccupation | 21.6 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | Baseline- Cognitive avoidance | 10.1 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | Baseline-Fatalism | 15.6 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | Baseline- Fighting spirit | 13.4 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | Baseline- Helplessness/hopelessness | 13.0 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 4 weeks - Anxious preoccupation | 19.2 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 4 weeks - Cognitive avoidance | 6.3 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 4 weeks - Fatalism | 15.7 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 4 weeks -Fighting spirit | 13.8 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 8 weeks- Anxious preoccupation | 12.2 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 8 weeks- Cognitive avoidance | 7.5 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 8 weeks- Fighting spirit | 11.0 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (MAC) | 8 weeks- Helplessness/hopelessness | 9.8 score on a scale |
p-value: 0.771195% CI: [-6.2, 4.9]t-test, 2 sided
p-value: 0.077295% CI: [-11.5, 0.8]t-test, 2 sided
p-value: 0.245295% CI: [-2.9, 8.9]t-test, 2 sided
p-value: 0.609995% CI: [-10.5, 6.8]t-test, 2 sided
p-value: 0.091395% CI: [-6.7, 0.7]t-test, 2 sided
Secondary
Changes in Depression and Anxiety Levels (PIL)
Three instruments will provide information on baseline, Visit 8, and change over time. 2\) The Purpose in Life Test (PIL) - 20-item, 7-point Likert scale designed to measure the extent to which a respondent perceives a general sense of meaning and purpose in life using varying scale labels, scores are aggregated with a minimum score of 20 (lowest purpose) and a maximum score of 140 (highest purpose).
Time frame: At baseline up to 8 weeks
Population: Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TeleHealth Group | Changes in Depression and Anxiety Levels (PIL) | Baseline | 76.4 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (PIL) | 4 weeks | 79.3 score on a scale |
| TeleHealth Group | Changes in Depression and Anxiety Levels (PIL) | 8 weeks | 76.3 score on a scale |
p-value: 0.791895% CI: [-11.3, 9.1]t-test, 2 sided