Ovarian CancerCOACHNCT05349227
Comprehensive Outcomes for After Cancer Health
A study testing Digital Health Coaching Program and Fitbit in people with Ovarian Cancer and Breast Cancer, run by Pack Health at 7 sites in United States.
Trial summary
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Breast Cancer, Lung Cancer
- What is being tested?
- Digital Health Coaching Program and Fitbit
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 7 sitesUnited States
- Study dates
- 23 Jun 2022to May 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have primary diagnosis of cancer;
- Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer
- For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy
- For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic disease within the last year, are within one year of completion of initial therapy for their primary cancer diagnosis for which disease progression has occurred, or who are within one year of receiving treatment for metastatic disease (including individuals currently receiving treatment).
- Are aged 18 years and older;
- Can read and consent to participate in the trial;
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- Can read and speak English;
- Can complete study follow-up at pre-specified intervals;
- Have access to mobile technology (e.g. a smart phone or tablet) that would allow engagement in digital health coaching for the collection of PROs and wearable data.
Who cannot join
- Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments;
- Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)
- Have a life expectancy of \<6 months, and/or
- Are on active treatment for relapsed disease. a. Individuals with disease progression or relapse which occurs following their consent to participate will be given the option to continue on study if they wish to do so. Data from individuals experiencing disease progression or relapse will be grouped for sub-analysis to explore if and how relapse impacts study outcomes.
- Healthy Volunteers must:
- Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.
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- Must reside in the same dwelling as the patient participant
- Can read and consent to participate in the trial;
- Can read and speak English;
- Can complete study follow-up at pre-specified intervals;
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 4 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Marilyn Hammer, PhD, 347-271-0293, marilynj_hammer@dfci.harvard.edu
Alexi Wright, MD, MPH, 617-632-2334, Alexi_Wright@dfci.harvard.edu
- Active, not recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
- Active, not recruiting
The University of Florida
Gainesville, Florida, 32610
- Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Kathrin Milbury, PhD, 713-745-2868, kmilbury@mdanderson.org
Meagan Whisenant, PhD, 713-500-2279, meagan.whisenant@uth.tmc.edu
- Recruiting
UT Health Houston
Houston, Texas, 77030
Kaukab I Jafry, MD, MBBS, 832 325 6537, Kaukab.I.Jafry@uth.tmc.edu
Martha Thompson, 832-325-7706, Martha.Thompson@uth.tmc.edu
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Kristen L Fessele, PhD, 646-449-1076, nuronr@mskcc.org
Kristen L Fessele, PhD
- Active, not recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68106
About this study
Official title: Comprehensive Outcomes for After Cancer Health (COACH): the Feasibility and Impact of an MHealth Augmented Coaching Program for Self-Management in Cancer Survivors
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.
Read the detailed description
Background: There are an estimated 16.9 million cancer survivors in the United States, accounting for approximately 5% of the entire US population, and this number is anticipated to increase by 31% over the next 10 years to include 22.2 million individuals.1 Due to advances in therapy individuals with cancer are experiencing increased overall survival that is often accompanied by the management of cancer as a chronic condition.2 As such many individuals require maintenance therapies that extend for months or years beyond the completion of primary therapy with surgery, radiation, and/or pharmacologic therapies. Chronic management of cancer care may include both long-term maintenance therapy as well as the management of treatment-related sequelae, the majority of which occurs beyond the clinical setting. Supportive care needs include symptom support, general wellness, and a focus on the importance of adherence to treatment and follow-up, all of which may influence quality and quantity of life. Accordingly, there is a critical and growing need for comprehensive, accessible platforms to support survivor self-management of symptoms and general wellness (including physical, functional, and psychosocial well-being and healthcare adherence). There is furthermore a critical knowledge gap on the correlation between individual symptoms and wellness on novel biomarkers, specifically intestinal (gut) microbiome. Gut microbiome regulates critical physiological processes-digestion, mood, and overall immune health, but to date studies have focused on dysbiosis during cancer treatment. The investigators seek to explore dynamics of gut microbiota after cancer treatment and understand how health behavioral changes prompted by health coaching to modulate symptoms and physical/ psychosocial well-being may also positively influence the restoration of gut flora.
Aims: The objective of this randomized, wait-list control study is to assess the effect of a 6-month digital health coaching program in cancer survivors within 1 year of primary treatment and longitudinally measure its impact on multifaceted health outcomes. The investigators aim to: 1) Primarily, assess the feasibility, acceptability, and effect of digital health coaching on participants' health self-efficacy; 2) Secondarily, characterize associations between participant symptoms, physical/psychosocial well-being, and health self-management and gut microbiota changes; and 3) Explore patient-generated health data outcomes among participants (patient-reported [PROs] and wearable biometrics outcomes).
Methods: The proposed study will utilize a randomized-wait list control design to enroll up to 625 individuals with diverse tumor types who have completed primary treatment and are within 1 year of diagnosis. Each of up to 8 collaborating sites will enroll up to 100 participants. Participants will be enrolled in a 6-month digital health coaching program that combines person-to-person calls once weekly, accompanied by up to 4 digital nudges of evidence-based content via text, email and/or mobile application, based on the participant's preference. Content will focus on key topics designed to optimize survivorship outcomes, including management of late and long-term effects of therapy, diet and exercise, fatigue, financial toxicity, and other associated symptoms (e.g., sleep disturbance, depression), medication adherence, surveillance, and managing anxiety and fear of cancer recurrence. The program emphasizes targeting modifiable behaviors that can improve quality of life and health outcomes, including progression-free and overall survival. Those randomized to the intervention group will receive the 6-month coaching intervention up front followed by 6 months of on-going clinical, patient reported, activity, and microbiome data collection. Those randomized to the control will receive 6-months of clinical, patient reported, activity, and microbiome data collection, after which they will be randomized to the digital health coaching intervention.
Outcome Measures: All participants will be followed for 12-months during which time they will be provided with Fitbit devices to track engagement in physical activity. Microbiome samples will be collected at enrollment and 6 months to explore biomarkers of inflammation, which will be analyzed to examine associations between microbiota signatures and engagement in physical activity and PROs. Genomic bacterial DNA will be extracted and analyzed for any taxonomic changes in the microbiota diversity and composition with 16s rRNA sequencing. Microbiome analysis will be conducted in partnership with The National Institute of Nursing Research (NINR). PROs will be collected at baseline and months 3, 6, 9, and 12 to track progress during and following the program and to provide insights into the experience of quality of life, symptom burden, mental health, cognitive function, sleep quality, sexual health, and financial toxicity.
Rationale: This program seeks to address survivors' total well-being, including co-morbid conditions, psychosocial wellness, and healthy lifestyle behaviors, to enhance outcomes for individuals who have completed primary therapy for a cancer diagnosis. The approach is innovative in exploring how digital health coaching may be used to support the holistic needs of cancer survivors beyond the clinical care setting. The robust collection of patient-reported, wearable, biomarker, and clinical data, as well as qualitative data related to patient priorities, concerns and challenges in the context of Health Coaching, will allow for triangulation of data to comprehensively inform the experience of individuals following primary therapy as they manage their health in the community setting.
- Conditions
- Ovarian Cancer, Breast Cancer, Lung Cancer, Gastric Cancer, Survivorship, Endometrial Cancer
- Being tested
- Digital Health Coaching Program, Fitbit
- Keywords
- Patient Reported Outcome Measures, Physical Activity, Digital Coaching, Microbiome, Wearables
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Lung Neoplasms, Stomach Neoplasms, Endometrial Neoplasms, Head and Neck Neoplasms, Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Coaching ProgramBehavioural
Coaching consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.
FitbitDevice
Device: Fitbit A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In addition to standard of care services at the participant's respective health system, and study specific collection of clinical, PRO, and wearable data, as well as microbiome specimens, individuals randomized to the intervention group will receive immediate enrollment to a 6-month digital health coaching program followed by 6 months monitoring via PRO, wearable, and clinical data collection. They will collect fecal microbiome samples at baseline (study enrollment) and month 6 following enrollment. Receives: Behavioral: Digital Health Coaching Program; Device: Fitbit |
| Wait List Control Group | Other | In addition to standard of care services, individuals in the wait list control will be monitored via the collection of PRO, clinical, and wearable data for the first 6 months, along with fecal microbiome collection at study enrollment baseline (study enrollment) and month 6. At month 6 these individuals will be enrolled into the 6-month digital health coaching program, during which clinical, PRO and wearable data will continue to be collected. At the completion of the 6-month coaching these individuals will come off study and will not receive additional follow-up. Receives: Behavioral: Digital Health Coaching Program; Device: Fitbit |
| Household Healthy Participants | No intervention | A cohort of consisting of adults without a cancer diagnosis residing in the same residence as participants, will be consented to collect fecal microbiome specimens to serve as a control for potential regional variation in microbiome dysbiosis. Up to 25 healthy controls will be enrolled per 100 participants at each study site. At sites enrolling fewer than 100 participants, an n up to 25% of the total patient enrollment sample will be approached for enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of coaching intervention
A 3-item questionnaire evaluating the following: 1) The digital health coaching program is easy to participate in; 2) the digital health coaching program is useful to me; 3) the digital health coaching program is relevant to my survivorship experience. Responses will be provided on a 10-point Likert scale ranging from 1 (Not at all) to 10 (Very Much).
Measured: At 6 months following the start of the coaching intervention
Feasibility of coaching intervention
A retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the digital health coaching program completing the 6-months of engagement post-enrollment.
Measured: At 6 months following the start of the coaching intervention
Change in Self-Efficacy for Managing Chronic Disease
A 6-item instrument measures how confident an individual is in engaging in certain health management activities. Responses are provided on a 10-point scale ranging from 1(not at all confident) to 10 (totally confident). A mean score is calculated for the instrument with a higher score indicating higher self-efficacy.
Measured: Change in baseline perception of self-efficacy at 12 months
Secondary outcomes (11)
Change in the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Physical Function 10a
A 12-item instrument assessing respondents' abilities to perform physical tasks and activities of daily living. Items are scored on 5-point Likert scales, with higher scores indicating higher physical functioning.
Measured: Change in baseline perception of physical function at 12 months
Change in Quality of Life as measured by The Functional Assessment of Cancer Therapy - General v4 (FACT-G)
A 27-item instrument using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much) to measure QoL across four dimensions: physical, social/family, emotional and functional. The FACT-G, validated for use with individuals with diverse cancer types, in addition to condition specific items as available by tumor type.
Measured: Change in baseline perception of quality of life at 12 months
Change in Anxiety as measured by the PROMIS Anxiety Short Form 8a
An 8-item instrument measuring indicators of anxiety with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater anxiety.
Measured: Change in baseline perception of anxiety at 12 months
Change in Depression as measured by the PROMIS Depression Short Form 8a
An 8-item instrument measuring indicators of depression with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater depression.
Measured: Change in baseline perception of depression at 12 months
Change in Cognitive Function as measured by the PROMIS Cognitive Function Short Form 8a
An 8-item instrument measuring indicators of cognitive function with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater cognitive impairment.
Measured: Change in baseline perception of cognitive impairment at 12 months
Change in Sleep-related Impairment as measured by the PROMIS Sleep related Impairment Short Form 8a
An 8-item instrument measuring indicators of sleep-related impairment with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater sleep-related impairment.
Measured: Change in baseline perception of cognitive impairment at 12 months
Change in the PROMIS Brief Sexual Function & Satisfaction Measure Male
An 11-item instrument measuring indicators of male sexual function and satisfaction with a recall period over the last 30 days. Responses are provided on various 2- to 10-point scales across 10 domains: interest in sexual activity, orgasm ability, orgasm satisfaction, oral discomfort, oral dryness, satisfaction with sex life, erectile function. For each item on the instrument a higher score indicates more of the concept being described.
Measured: Change in baseline perception of sexual function and satisfaction at 12 months among male participants
Change in the PROMIS Brief Sexual Function & Satisfaction Measure Female
A 14-item instrument measuring sexual function and satisfaction for women with a recall period over the last 30 days. Responses are provided on various 2- to 10-point scales across 7 domains: interest in sexual activity, lubrication for sexual activity, orgasm ability, orgasm pleasure, oral discomfort, oral dryness, satisfaction with sex life, vaginal discomfort, vulvar discomfort-clitoral, vulvar discomfort-labial. For each item on the instrument a higher score indicates more of the concept being described.
Measured: Change in baseline perception of sexual function and satisfaction at 12 months among female participants
Change in The Comprehensive Score for Financial Toxicity (COST)
An 11-item instrument measuring the financial toxicity of cancer treatment utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).
Measured: Change in baseline perception of financial toxicity at 12 months
Change in Economic Strain and Resilience in Cancer (ENRICh)
An 16-item instrument measuring the financial toxicity of cancer treatment. The first 15 items are rated on an 11-point scale ranging from 0 (lowest financial toxicity burden) to 10 (most severe financial toxicity burden). A final item asks individuals to rank their overall financial situation at the time of the survey compared to prior to their cancer diagnosis, using a 5-point response ranging from much better to much worse.
Measured: Change in baseline perception of financial toxicity at 12 months
Change in symptom burden as measured by the Edmonton Symptom Assessment System-Revised (ESAS-R)
A 10-item instrument measuring the presence of commonly observed symptoms in individuals with a cancer diagnosis (9 specific items and 1 allowing entry of other problems). Responses for a recall period of the last 24 hours are recorded on an 11-point scale ranging from 0 (none/not present) to 10 (worst possible).
Measured: Change in baseline perception of symptom burden at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start23 Jun 2022
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (94)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies 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
- Crossover
- Model description
- Wait list control trial in which up to 625 patients will be randomized to receive either 6-months of digital coaching immediately followed by 6-months of monitoring or 6-months of monitoring followed by 6-months of digital health coaching. All participants will receive 12 months of patient reported outcomes collection and activity tracking via wrist-worn devices, as well as microbiome collection at baseline and month 6 only.
- Masking
- None (open label)
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pack Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo, GlaxoSmithKline, University of Nebraska, Ohio State University Comprehensive Cancer Center, The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center, University of Florida, Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, Gilead Sciences, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Marilyn Hammer, PhD, Principal investigator, Dana-Farber Cancer InstituteAlexi Wright, MD, Principal investigator, Dana-Farber Cancer InstituteElizabeth Arthur, PhD, Principal investigator, Ohio State UniversityJessica Krok-Schoen, PhD, Principal investigator, Ohio State UniversityRobin Lally, PhD, Principal investigator, The University of NebraskaRachael Schmidt, DNP, Principal investigator, Nebraska MedicineDebra E Lyon, PhD, Principal investigator, University of Florida College of NursingAnneliese Gonzalez, MD, Principal investigator, UTHealth Houston McGovern Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349227
- Sponsor's protocol ID
- 202101
- Other IDs
- ZIANR000020-06
- Acronym
- COACH
- Status last verified
- Sep 2024
- First submitted
- 14 Apr 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
PubMed 11769298McCorkle R, Ercolano E, Lazenby M, Schulman-Green D, Schilling LS, Lorig K, Wagner EH. Self-management: Enabling and empowering patients living with cancer as a chronic illness. CA Cancer J Clin. 2011 Jan-Feb;61(1):50-62. doi: 10.3322/caac.20093. Epub 2011 Jan 4.
PubMed 21205833Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.
PubMed 25091546Jensen RE, Potosky AL, Reeve BB, Hahn E, Cella D, Fries J, Smith AW, Keegan TH, Wu XC, Paddock L, Moinpour CM. Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients. Qual Life Res. 2015 Oct;24(10):2333-44. doi: 10.1007/s11136-015-0992-9. Epub 2015 May 3.
PubMed 25935353Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
PubMed 9095563Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
PubMed 9060536Basen-Engquist K, Bodurka-Bevers D, Fitzgerald MA, Webster K, Cella D, Hu S, Gershenson DM. Reliability and validity of the functional assessment of cancer therapy-ovarian. J Clin Oncol. 2001 Mar 15;19(6):1809-17. doi: 10.1200/JCO.2001.19.6.1809.
PubMed 11251013Garland SN, Pelletier G, Lawe A, Biagioni BJ, Easaw J, Eliasziw M, Cella D, Bathe OF. Prospective evaluation of the reliability, validity, and minimally important difference of the functional assessment of cancer therapy-gastric (FACT-Ga) quality-of-life instrument. Cancer. 2011 Mar 15;117(6):1302-12. doi: 10.1002/cncr.25556. Epub 2010 Oct 19.
PubMed 20960518Clover K, Lambert SD, Oldmeadow C, Britton B, King MT, Mitchell AJ, Carter G. PROMIS depression measures perform similarly to legacy measures relative to a structured diagnostic interview for depression in cancer patients. Qual Life Res. 2018 May;27(5):1357-1367. doi: 10.1007/s11136-018-1803-x. Epub 2018 Feb 8.
PubMed 29423755Jensen RE, Moinpour CM, Potosky AL, Lobo T, Hahn EA, Hays RD, Cella D, Smith AW, Wu XC, Keegan TH, Paddock LE, Stroup AM, Eton DT. Responsiveness of 8 Patient-Reported Outcomes Measurement Information System (PROMIS) measures in a large, community-based cancer study cohort. Cancer. 2017 Jan 1;123(2):327-335. doi: 10.1002/cncr.30354. Epub 2016 Oct 3.
PubMed 27696377Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol. 2016 May;73:119-27. doi: 10.1016/j.jclinepi.2015.08.036. Epub 2016 Feb 27.
PubMed 26931289Valentine TR, Weiss DM, Jones JA, Andersen BL. Construct validity of PROMIS(R) Cognitive Function in cancer patients and noncancer controls. Health Psychol. 2019 May;38(5):351-358. doi: 10.1037/hea0000693.
PubMed 31045417Iverson GL, Marsh JM, Connors EJ, Terry DP. Normative Reference Values, Reliability, and Item-Level Symptom Endorsement for the PROMIS(R) v2.0 Cognitive Function-Short Forms 4a, 6a and 8a. Arch Clin Neuropsychol. 2021 Oct 13;36(7):1341-1349. doi: 10.1093/arclin/acaa128.
PubMed 33454756Jerath R, Cearley SM, Jensen M. Widespread membrane potential changes and cardiorespiratory synchronization involved in anxiety and sleep-wake transitions. J Biol Regul Homeost Agents. 2016 Oct-Dec;30(4):935-944.
PubMed 28078839Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.
PubMed 22250775