Trial Outcomes & Findings for Cancer Within a Pandemic: A Telemental Health Intervention (NCT NCT04659993)

Last Updated: 2025-10-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

At baseline up to 8 weeks

Results posted on

2025-10-16

Participant Flow

Among the eligible recruitment pool, direct staff member referrals were most common. The final group was comprised primarily of referrals from existing databases.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study Pre-intervention Assessment	7
Overall Study Telehealth Intervention	8
Overall Study Mid-point Evaluation	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

Cancer Within a Pandemic: A Telemental Health Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TeleHealth Group n=8 Participants 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.
Age, Continuous	26 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	8 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants
Work/Study Location Home	6 Participants n=5 Participants
Work/Study Location Office or School	2 Participants n=5 Participants
Marital Status Single	5 Participants n=5 Participants
Marital Status Married	1 Participants n=5 Participants
Marital Status Divorced	1 Participants n=5 Participants
Marital Status Widowed	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline up to 8 weeks

Population: Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks.

Outcome measures

Outcome measures
Measure	TeleHealth Group n=7 Participants 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.
Change in Self-Efficacy in Pandemic Conditions Baseline	86.7 score on a scale Interval 75.2 to 98.3
Change in Self-Efficacy in Pandemic Conditions 4 weeks	87.0 score on a scale Interval 66.1 to 107.9
Change in Self-Efficacy in Pandemic Conditions 8 weeks	87.8 score on a scale Interval 68.5 to 107.2

SECONDARY outcome

Timeframe: At baseline up to 8 weeks

Population: Seven participants completed instruments at Baseline, 6 at 4 weeks and 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.

Outcome measures

Outcome measures
Measure	TeleHealth Group n=7 Participants 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.
Changes in Depression and Anxiety Levels (CAS) Baseline	1.0 score on a scale Interval -0.8 to 2.8
Changes in Depression and Anxiety Levels (CAS) 4 weeks	0.8 score on a scale Interval -0.8 to 2.5
Changes in Depression and Anxiety Levels (CAS) 8 weeks	0.2 score on a scale Interval -0.3 to 0.6

SECONDARY outcome

Timeframe: At baseline up to 8 weeks

Population: Seven participants completed instruments at Baseline, 6 at 4 weeks and 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).

Outcome measures

Outcome measures
Measure	TeleHealth Group n=7 Participants 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.
Changes in Depression and Anxiety Levels (PIL) Baseline	76.4 score on a scale Interval 71.2 to 81.6
Changes in Depression and Anxiety Levels (PIL) 4 weeks	79.3 score on a scale Interval 67.9 to 90.7
Changes in Depression and Anxiety Levels (PIL) 8 weeks	76.3 score on a scale Interval 61.1 to 91.5

SECONDARY outcome

Timeframe: At baseline up to 8 weeks

Population: Seven participants completed instruments at Baseline, 6 at 4 weeks and 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).

Outcome measures

Outcome measures
Measure	TeleHealth Group n=7 Participants 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.
Changes in Depression and Anxiety Levels (MAC) Baseline-Anxious preoccupation	21.6 score on a scale Interval 15.2 to 28.0
Changes in Depression and Anxiety Levels (MAC) Baseline- Cognitive avoidance	10.1 score on a scale Interval 6.3 to 14.0
Changes in Depression and Anxiety Levels (MAC) Baseline-Fatalism	15.6 score on a scale Interval 12.4 to 18.7
Changes in Depression and Anxiety Levels (MAC) Baseline- Fighting spirit	13.4 score on a scale Interval 11.4 to 15.4
Changes in Depression and Anxiety Levels (MAC) Baseline- Helplessness/hopelessness	13.0 score on a scale Interval 9.4 to 16.6
Changes in Depression and Anxiety Levels (MAC) 4 weeks - Anxious preoccupation	19.2 score on a scale Interval 10.4 to 28.0
Changes in Depression and Anxiety Levels (MAC) 4 weeks - Cognitive avoidance	6.3 score on a scale Interval 4.2 to 8.5
Changes in Depression and Anxiety Levels (MAC) 4 weeks - Fatalism	15.7 score on a scale Interval 12.8 to 18.5
Changes in Depression and Anxiety Levels (MAC) 4 weeks -Fighting spirit	13.8 score on a scale Interval 11.8 to 15.9
Changes in Depression and Anxiety Levels (MAC) 4 weeks -Helplessness/hopelessness	11.5 score on a scale Interval 5.8 to 17.2
Changes in Depression and Anxiety Levels (MAC) 8 weeks- Anxious preoccupation	12.2 score on a scale Interval 6.4 to 17.9
Changes in Depression and Anxiety Levels (MAC) 8 weeks- Cognitive avoidance	7.5 score on a scale Interval 2.5 to 12.5
Changes in Depression and Anxiety Levels (MAC) 8 weeks- Fatalism	15.8 score on a scale Interval 13.1 to 18.6
Changes in Depression and Anxiety Levels (MAC) 8 weeks- Fighting spirit	11.0 score on a scale Interval 6.6 to 15.4
Changes in Depression and Anxiety Levels (MAC) 8 weeks- Helplessness/hopelessness	9.8 score on a scale Interval 7.1 to 12.6

Adverse Events

TeleHealth Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Phone: 3367135440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place