Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT04337203
The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Primary Objectives:
Secondary Objectives:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Children under the age of 18 with cancer will be excluded due to the potentially different self-management support intervention needs of this population that will likely include parental involvement. Results from this research may inform future studies in children with cancer under 18 who should be researched separately.
Exclusion criteria
The program consists of three components: An electronic referral among clinical teams for potential participants, patient engagement with survivorship care planning guidelines through self-management/health coaching. One coaching call before a clinic visit (60 minutes) and two coaching calls after the clinic visit (30 minutes each). Participants will also receive automated, tailored text messages (daily for three weeks before and after a clinic visit for a total of six weeks).
Time frame: 1 year, 8 months
Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S.
Time frame: 1 year, 8 months
Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S
Time frame: Up to 30 days after the final intervention session.
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability.
Time frame: Up to 30 days after the final intervention session.
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness.
Time frame: 1 year, 8 months
This will be defined as the average number of participants that enroll per month that the study is open to enrollment.
Time frame: Up to 30 days after the final intervention session.
This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility.
Time frame: Up to 30 days after the final intervention session.
Retention is defined as participants that complete the follow up assessment.
Time frame: 1 year, 8 months
Defined as participants that adhere to responding to text messages received during intervention.
Time frame: 1 year, 8 months
Defined as adherence to completing coaching sessions during the intervention.
Time frame: Up to 30 days after the final intervention session.
Defined as how long each completed coaching sessions lasted during the intervention.
Time frame: 1 year, 8 months
Defined as an observational checklist completed for a subset of coaching sessions.
Time frame: 1 year, 8 months
Number of patients enrolled will be defined as overall participants for the entirety of the study.
Time frame: Up to 30 days after the final intervention session.
Adverse events related to the intervention will be assessed in adverse event log.
Time frame: Up to 30 days after the final intervention session.
Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication.
Time frame: At baseline and up to 30 days after the final intervention session.
Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct.
Time frame: At baseline and up to 30 days after the final intervention session.
Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health.
Time frame: At baseline and up to 30 days after the final intervention session.
Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings.
Time frame: At baseline and up to 30 days after the final intervention session.
The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = "not at all true", 2 = "a bit true", 3 = "somewhat true", 4 = "mostly true", and 5 = "completely true." Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning.
Time frame: At baseline and up to 30 days after the final intervention session.
A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy.
Time frame: 1 year, 8 months
Self-reported use of the care plan since enrolled on the study.
Time frame: Up to 30 days after the final intervention session.
Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good.
Time frame: At baseline and up to 30 days after the final intervention session.
Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users.
Time frame: At baseline and up to 30 days after the final intervention session.
Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous.
Time frame: At baseline and up to 30 days after the final intervention session.
Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with <90 minutes considered insufficient.
Time frame: At baseline and up to 30 days after the final intervention session.
Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient.
Time frame: At baseline and up to 30 days after the final intervention session.
Participants will be asked individual questions how many days/week they practice mindfulness.
Wake Forest University Health Sciences
Other
SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic Systems in Survivorship
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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