Trial Outcomes & Findings for CONNECTing Head and Neck Caregivers to Supportive Care Resources (NCT NCT03875885)

Results Overview

Number of caregivers who agreed to participate divided by the number of months of recruitment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

19 months

Results posted on

2023-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	CONNECT Intervention Group - Group A A web-based intervention (CONNECT) to empower and connect caregivers of newly diagnosed cancer patients to supportive care resources A randomized pilot study will be conducted to assess feasibility and acceptability and obtain data on caregiver and patient outcomes. CONNECT e-tool, re-education and optional referral (2 weeks post CONNECT e-tool). Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONNECT: A novel web-based intervention with input from an advisory panel of cancer caregivers, oncology providers, and psychosocial oncology professionals empowering caregivers with needs to seek services by providing education about the benefits of supportive care resources, systematically identifying their unmet needs, and connecting them with tailored supportive care resources.	CONNECT Comparison Group - Group B Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONTROL: This group will receive a generic resource list. The generic resource list will be printed for participants and emailed to them, if participants have an email address.
Overall Study STARTED	18	22
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CONNECTing Head and Neck Caregivers to Supportive Care Resources

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CONNECT Intervention Group - Group A n=18 Participants A web-based intervention (CONNECT) to empower and connect caregivers of newly diagnosed cancer patients to supportive care resources A randomized pilot study will be conducted to assess feasibility and acceptability and obtain data on caregiver and patient outcomes. CONNECT e-tool, re-education and optional referral (2 weeks post CONNECT e-tool). Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONNECT: A novel web-based intervention with input from an advisory panel of cancer caregivers, oncology providers, and psychosocial oncology professionals empowering caregivers with needs to seek services by providing education about the benefits of supportive care resources, systematically identifying their unmet needs, and connecting them with tailored supportive care resources.	CONNECT Comparison Group - Group B n=22 Participants Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. CONTROL: This group will receive a generic resource list. The generic resource list will be printed for participants and emailed to them, if participants have an email address.	Total n=40 Participants Total of all reporting groups
Age, Customized Age 18-35	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized Age 36-54	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized Age 55-72	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized Age unknown	11 Participants n=5 Participants	18 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Some College Education	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Married/ Partnered to Patient	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Adult Children to Patient	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Partnered. Married	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 19 months

Population: The 40 participants that agreed to participate in the intervention were accrued over a total of 19 months.

Number of caregivers who agreed to participate divided by the number of months of recruitment

Outcome measures

Outcome measures
Measure	Accrual n=40 Participants Total number of caregivers that agreed to participate divided by the number of months of recruitment.
Proportion of Caregivers Who Agree to Participate	2.1 participants per month

PRIMARY outcome

Timeframe: 9 months

Population: Out of 108 participants found to be eligible to participate in the study intervention only 40 agreed and consented to begin the study intervention.

Number of eligible participants who agreed to participate

Outcome measures

Outcome measures
Measure	Accrual n=108 Participants Total number of caregivers that agreed to participate divided by the number of months of recruitment.
Number of Eligible Participants	40 Participants

PRIMARY outcome

Timeframe: 9 months

Number of participants who completed the T2 assessment divided by the number who agreed to participate

Outcome measures

Outcome measures
Measure	Accrual n=40 Participants Total number of caregivers that agreed to participate divided by the number of months of recruitment.
Number of Retention of Participants	32 Participants

PRIMARY outcome

Timeframe: 9 months

Population: The acceptability measures were obtained from only 1 arm (intervention arm, since the questions pertain to the acceptability of the intervention), and were asked at the final time point, which means the n is those left in the intervention arm at the last time point.

Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a \~30min (approximately) qualitative interview to further explore acceptability (measures were not at all helpful, a little helpful, somewhat helpful or quite a bit helpful).

Outcome measures

Outcome measures
Measure	Accrual n=12 Participants Total number of caregivers that agreed to participate divided by the number of months of recruitment.
Acceptability - (Intervention Arm Only) Educational video on the CONNECT website (step 1 in guide) · Somewhat helpful	5 Participants
Acceptability - (Intervention Arm Only) Educational video on the CONNECT website (step 1 in guide) · Not at all helpful	1 Participants
Acceptability - (Intervention Arm Only) Educational video on the CONNECT website (step 1 in guide) · A little helpful	3 Participants
Acceptability - (Intervention Arm Only) Educational video on the CONNECT website (step 1 in guide) · Quite a bit helpful	3 Participants
Acceptability - (Intervention Arm Only) Online survey to identify the types of resources/services that might be helpful as a caregiver · Not at all helpful	2 Participants
Acceptability - (Intervention Arm Only) Online survey to identify the types of resources/services that might be helpful as a caregiver · A little helpful	2 Participants
Acceptability - (Intervention Arm Only) Online survey to identify the types of resources/services that might be helpful as a caregiver · Somewhat helpful	4 Participants
Acceptability - (Intervention Arm Only) Online survey to identify the types of resources/services that might be helpful as a caregiver · Quite a bit helpful	4 Participants
Acceptability - (Intervention Arm Only) List of supportive care resources · Not at all helpful	2 Participants
Acceptability - (Intervention Arm Only) List of supportive care resources · A little helpful	2 Participants
Acceptability - (Intervention Arm Only) List of supportive care resources · Somewhat helpful	5 Participants
Acceptability - (Intervention Arm Only) List of supportive care resources · Quite a bit helpful	3 Participants
Acceptability - (Intervention Arm Only) Referral option immediately upon completing the survey to identify resource interest · Not at all helpful	1 Participants
Acceptability - (Intervention Arm Only) Referral option immediately upon completing the survey to identify resource interest · A little helpful	2 Participants
Acceptability - (Intervention Arm Only) Referral option immediately upon completing the survey to identify resource interest · Somewhat helpful	7 Participants
Acceptability - (Intervention Arm Only) Referral option immediately upon completing the survey to identify resource interest · Quite a bit helpful	2 Participants
Acceptability - (Intervention Arm Only) 2 week follow up phone call to discuss available resources · Not at all helpful	1 Participants
Acceptability - (Intervention Arm Only) 2 week follow up phone call to discuss available resources · A little helpful	2 Participants
Acceptability - (Intervention Arm Only) 2 week follow up phone call to discuss available resources · Somewhat helpful	6 Participants
Acceptability - (Intervention Arm Only) 2 week follow up phone call to discuss available resources · Quite a bit helpful	1 Participants

PRIMARY outcome

Timeframe: 9 months

Population: The acceptability measures were obtained from only 1 arm (intervention arm, since the questions pertain to the acceptability of the intervention), and were asked at the final time point, which means the n is those left in the intervention arm at the last time point.

Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a \~30min (approximately) qualitative interview to further explore acceptability (measures were strongly agree, agree and undecided).

Outcome measures

Outcome measures
Measure	Accrual n=14 Participants Total number of caregivers that agreed to participate divided by the number of months of recruitment.
Acceptability - (Intervention Arm Only) Agree	7 Participants
Acceptability - (Intervention Arm Only) Undecided	5 Participants
Acceptability - (Intervention Arm Only) Strongly Agree	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

A 12-item instrument measuring physical and mental well-being, though our analyses will focus on physical well-being; widely used in oncology populations. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Unplanned healthcare utilization survey will be calculated using a one item continuous score. The survey will capture patient self-reported unplanned healthcare utilization (number of unplanned visits to the emergency room, urgent care, or healthcare provider) from time points of baseline to end of treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

A 20-item instrument with 4 subscales to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Participants will answer questions to indicate how satisfied they are with care family member has received. (Subscales = (S) satisfied, (U) undecided, (D) dissatisfied or (VD) very dissatisfied

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of interest, meaning, and purpose.Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

A 39-item instrument that measures physical, social, emotional, and functional well-being, as well as additional head and neck-related concerns. Scoring scale is 0 = not at all to 4 = very much). Maximum score of 156. Higher scores indicate a better quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Adapted version of the 28-item Consumer-Based Cancer Care Value Index- Services and Resources instrument assessing use of services to meet multidimensional supportive needs. Intervention caregivers will also self-report service use by completing an auto-generated REDCap survey to query about utilization of the specific resources that each caregiver expressed interest in accessing.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

A 20-item instrument with 4 subscales to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Participants will answer questions to indicate how satisfied they are with care family member has received. (Subscales = (S) satisfied, (U) undecided, (D) dissatisfied or (VD) very dissatisfied

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Caregiver Reaction Assessment - 24-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Each item is rated on a 1 to 4 scale. 1 (not at all) 2 (somewhat) 3 (quite a bit) 4 (completely)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of interest, meaning, and purpose. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). Scoring scale is 0 = not at all to 4 = very much). Maximum score of 140. Higher scores indicate better quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

A 7-item measure to assess caregiver behaviors for managing self-care. Questions are answered Yes or No and is a summation of the number of risks. Score range of 0-7, the higher the number, the greater the risk.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Survey responses will be coded as "adhered" or "did not adhere" for agency- and caregiver- reported service utilization. The score reporting is a dichotomous outcome of an adhered or not adhered.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions). Uses a likert scale from 1 (not at all confident) to 9 (totally confident). Higher scores indicate higher self-efficacy for coping with cancer.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

A 16-item survey with an additional "other" category for a caregiver to report additional barriers not noted on the survey. Response options range from never (0) to always (4). Higher scores indicate a greater number of barriers.

Outcome measures

Outcome data not reported

Adverse Events

CONNECT Intervention Group - Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CONNECT Comparison Group - Group B

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

Study Coordinator

Wake Forest Baptist Comprehensive Cancer Center

Phone: 336-713-0677

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place