DepressionPRO-YOUNCT02489422
Programs To Support You During Chemotherapy
A study testing Laboratory Biomarker Analysis, Questionnaire Administration and Daily Survey Administration in people with Depression and Fatigue, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression, Fatigue, Stage IIA Colorectal Cancer
- What is being tested?
- Laboratory Biomarker Analysis, Questionnaire Administration and Daily Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV)
- Have an Eastern Cooperative Oncology Group performance status of =< 1
- Ability to understand and the willingness to sign and informed consent document in English
Who cannot join
- Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: GI 1549: PROGRAMS TO SUPPORT YOU DURING CHEMOTHERAPY (PRO-YOU) A Randomized Controlled Pilot Study of Yoga Compared to an Attention Control in Patients Receiving Chemotherapy
This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.
Read the detailed description
PRIMARY OBJECTIVES:
- To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a caring attention control (AC) group among adults with colorectal cancer (CRC) receiving chemotherapy to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures.
SECONDARY OBJECTIVES:
- To measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments.
II. To qualitatively assess perceived efficacy of the YST and AC and acceptability of new methodology through semi-structured interviews in a subset of 20-40 participants.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (YST): Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
GROUP II (AC): Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, and 8.
After completion of study, patients are followed up at 4 weeks.
- Conditions
- Depression, Fatigue, Stage IIA Colorectal Cancer, Stage IIB Colorectal Cancer, Stage IIC Colorectal Cancer, Stage IIIA Colorectal Cancer
- Being tested
- Laboratory Biomarker Analysis, Questionnaire Administration, Daily Survey Administration, Yoga Skills Training, Attention Control
- Medical subject headings
- Depression, Fatigue, Colorectal Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms, Appendiceal Neoplasms, Stomach Neoplasms, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
Daily Survey AdministrationOther
Ancillary studies
Yoga Skills TrainingBehavioural
Also called yoga, YST
The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Attention ControlBehavioural
Also called empathic attention control, supportive conversation, caring attention control
The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy AssessmentOther
Also called Circadian Disruption - daily
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (Yoga Skills Training) | Experimental | Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Receives: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Daily Survey Administration; Behavioral: Yoga Skills Training; Other: Actigraphy Assessment |
| Group II (Attention Control) | Active comparator | Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Receives: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Daily Survey Administration; Behavioral: Attention Control; Other: Actigraphy Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
Measured: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Secondary outcomes (19)
Circadian Disruption (Daily)
Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
Measured: At 0-2 weeks after start of intervention
Circadian Disruption (Daily)
Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
Measured: At 8-10 weeks after start of intervention
Circadian Disruption (Recalled)
Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. 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 sleep disturbance.
Measured: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Depressive Symptoms Assessed by PROMIS
Will be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
Measured: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Fatigue (Daily)
Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.
Measured: At 0-2 weeks and 8-10 weeks after start of intervention
Depressive Symptoms (Daily)
Depressive symptoms will be assessed with 3 items selected from the PROMIS measure of depression validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive symptoms the participants exhibited. scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
Measured: At 0-2 weeks and 8-10 weeks after start of intervention
Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
Measured: At 2 weeks after start of intervention
Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. ). All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
Measured: At 10 weeks after start of intervention
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
Measured: At 2 weeks after start of intervention
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
Measured: At 10 weeks after start of intervention
Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
Measured: At 2 weeks after start of intervention
Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
Inflammatory cytokines (i.e., interleukin 6 [IL-6], soluble tumor necrosis factor receptor 1 [sTNF-R1], and tumor necrosis factor alpha [TNF-alpha]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
Measured: At 10 weeks after start of intervention
Psychological Stress Assessed by the Perceived Stress Scale (PSS)
Psychological stress will be assessed by the 10-item PSS. The PSS has 2 factors (stress and counter stress). Scoring scale range from 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often and 4 - very often. Score range is 0-40. A higher score represents more of the concept being measured.
Measured: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Psychological Stress Assessed by the PSS (Daily)
Psychological stress will be assessed daily with two items from the 4-item PSS that would be on the same factor to optimize internal consistency. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. A mean of the participants scores was taken.
Measured: At 0-2 weeks and 8-10 weeks after start of intervention
Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)
Regulation of psychological stress will be assessed daily with the 3-item serenity subscale (calm, relaxed, at ease) from the Positive and Negative Affect Schedule-Expanded Form. Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect.
Measured: At 0-2 weeks and 8-10 weeks after start of intervention
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
Regulation of psychological stress will be determined by ratings on four of the seven factors of the Cancer Behavior Inventory, which assess self-efficacy for stress management, coping with treatment-related side-effects, accepting cancer/maintaining positive attitude, and affective regulation. Scale ranged from 1-9 (1 - 3 not at all confident; 4-6 moderately confident and 7-9 totally confident). 4 of the 7 items from the Cancer Behavior Inventory (V2.0) were used with each item's score ranges from 0-50 with higher scores indicating more confidence in the item.
Measured: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Minutes of Home Practice Completed
Participants will keep daily paper logs of their home practice. In addition, one item will ask via the daily automated survey how many minutes participants practiced the intervention that day for two weeks after completion of the intervention.
Measured: Up 10 weeks after start of intervention
Percent of Planned In Person Intervention Sessions Attended
Percent of all assessments completed and timeliness of completion will be tracked.
Measured: At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention
Number of Participants With Successful Qualitative Data Collection
Qualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments. Qualitative information gained will enrich quantitative results and inform the protocol of a larger trial.
Measured: At 14 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startAug 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Stephanie Sohl, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489422
- Sponsor's protocol ID
- IRB00038321
- Other IDs
- NCI-2015-01042, CCCWFU 01716, K01AT008219, P30CA068485
- Acronym
- PRO-YOU
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2015
- Last updated
- 14 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GI 1549: PROGRAMS TO SUPPORT YOU DURING CHEMOTHERAPY (PRO-YOU) A Randomized Controlled Pilot Study of Yoga Compared to an Attention Control in Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT02489422
- Acronym / sponsor ID
- PRO-YOU / IRB00038321
- Conditions
- Depression, Fatigue, Stage IIA Colorectal Cancer, Stage IIB Colorectal Cancer, Stage IIC Colorectal Cancer, Stage IIIA Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Posted 27 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.
Detailed description
PRIMARY OBJECTIVES:
- To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a caring attention control (AC) group among adults with colorectal cancer (CRC) receiving chemotherapy to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures.
SECONDARY OBJECTIVES:
- To measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments.
II. To qualitatively assess perceived efficacy of the YST and AC and acceptability of new methodology through semi-structured interviews in a subset of 20-40 participants.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (YST): Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
GROUP II (AC): Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, and 8.
After completion of study, patients are followed up at 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Yoga Skills Training) | Experimental | Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Other: Daily Survey Administration, Behavioral: Yoga Skills Training, Other: Actigraphy AssessmentPatients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. |
| Group II (Attention Control) | Active comparator | Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Other: Daily Survey Administration, Behavioral: Attention Control, Other: Actigraphy AssessmentPatients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV)
- Have an Eastern Cooperative Oncology Group performance status of =< 1
- Ability to understand and the willingness to sign and informed consent document in English
Key exclusion criteria (1 listed)
- Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (Yoga Skills Training), Group II (Attention Control) |
| Questionnaire AdministrationAncillary studies | Other | Group I (Yoga Skills Training), Group II (Attention Control) |
| Daily Survey AdministrationAncillary studies | Other | Group I (Yoga Skills Training), Group II (Attention Control) |
| Yoga Skills TrainingAlso: yoga, YSTThe YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. | Behavioural | Group I (Yoga Skills Training) |
| Attention ControlAlso: empathic attention control, supportive conversation, caring attention controlThe AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. | Behavioural | Group II (Attention Control) |
| Actigraphy AssessmentAlso: Circadian Disruption - dailyAncillary studies | Other | Group I (Yoga Skills Training), Group II (Attention Control) |
Primary outcome
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
19 secondary outcomes
Circadian Disruption (Daily)
Time frame: At 0-2 weeks after start of intervention
Circadian Disruption (Daily)
Time frame: At 8-10 weeks after start of intervention
Circadian Disruption (Recalled)
Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Depressive Symptoms Assessed by PROMIS
Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Fatigue (Daily)
Time frame: At 0-2 weeks and 8-10 weeks after start of intervention
Depressive Symptoms (Daily)
Time frame: At 0-2 weeks and 8-10 weeks after start of intervention
Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
Time frame: At 2 weeks after start of intervention
Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
Time frame: At 10 weeks after start of intervention
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
Time frame: At 2 weeks after start of intervention
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
Time frame: At 10 weeks after start of intervention
Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
Time frame: At 2 weeks after start of intervention
Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
Time frame: At 10 weeks after start of intervention
Psychological Stress Assessed by the Perceived Stress Scale (PSS)
Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Psychological Stress Assessed by the PSS (Daily)
Time frame: At 0-2 weeks and 8-10 weeks after start of intervention
Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)
Time frame: At 0-2 weeks and 8-10 weeks after start of intervention
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
Time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Minutes of Home Practice Completed
Time frame: Up 10 weeks after start of intervention
Percent of Planned In Person Intervention Sessions Attended
Time frame: At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of intervention
Number of Participants With Successful Qualitative Data Collection
Time frame: At 14 weeks after start of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Sohl, MD principal investigator
Vanderbilt University/Ingram Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, Questionnaire Administration and Daily Survey Administration in people with Depression and Fatigue, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) (time frame: At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.