Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial)
Introduction Cancer-related fatigue (CRF) is one of the most common and debilitating adverse effects of cancer and its treatment reported by cancer survivors. Physical activity, psychological interventions and management of concurrent symptoms have been shown to be effective in alleviating CRF. This...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-05-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/5/e059952.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850284466643140608 |
|---|---|
| author | Jane Turner Nicolas H Hart Patsy Yates Laisa Teleni Joanne F Aitken Lee Jones Steven M McPhail Rahul Ladwa Fiona Crawford-Williams Raymond J Chan Mark B Pinkham Elizabeth P Pinkham Brigid Hanley Gemma Lock Jodie Nixon Oluwaseyifunmi Andi Agbejule Carmen P Escalante |
| author_facet | Jane Turner Nicolas H Hart Patsy Yates Laisa Teleni Joanne F Aitken Lee Jones Steven M McPhail Rahul Ladwa Fiona Crawford-Williams Raymond J Chan Mark B Pinkham Elizabeth P Pinkham Brigid Hanley Gemma Lock Jodie Nixon Oluwaseyifunmi Andi Agbejule Carmen P Escalante |
| author_sort | Jane Turner |
| collection | DOAJ |
| description | Introduction Cancer-related fatigue (CRF) is one of the most common and debilitating adverse effects of cancer and its treatment reported by cancer survivors. Physical activity, psychological interventions and management of concurrent symptoms have been shown to be effective in alleviating CRF. This pilot randomised controlled trial (RCT) will determine the feasibility of a telehealth CRF clinic intervention (T-CRF) to implement evidence-based strategies and assess the impact of the intervention on CRF and other clinical factors in comparison to usual care.Methods and analysis A parallel-arm (intervention vs usual care) pilot RCT will be conducted at the Princess Alexandra Hospital in Queensland, Australia. Sixty cancer survivors aged 18 years and over, who report moderate or severe fatigue on the Brief Fatigue Inventory and meet other study criteria will be recruited. Participants will be randomised (1:1) to receive the T-CRF intervention or usual care (ie, specialist-led care, with a fatigue information booklet). The intervention is a 24-week programme of three telehealth nurse-led consultations and a personalised CRF management plan. The primary objective of this pilot RCT is to determine intervention feasibility, with a secondary objective to determine preliminary clinical efficacy. Feasibility outcomes include the identification of recruitment methods; recruitment rate and uptake; attrition; adherence; fidelity; apathy; and intervention functionality, acceptability and satisfaction. Clinical and resource use outcomes include cancer survivor fatigue, symptom burden, level of physical activity, productivity loss, hospital resource utilisation and carer’s fatigue and productivity loss. Descriptive statistics will be used to report on feasibility and process-related elements additional to clinical and resource outcomes.Ethics and dissemination This trial is prospectively registered (ACTRN12620001334998). The study protocol has been approved by the Metro South Health and Hospital Services Human Research Ethics Committee (MSHHS HREC/2020/QMS/63495). Findings will be disseminated through peer-reviewed publications, national and international conferences and seminars or workshops.Trial registration number Australian New Zealand Clinical Trials Registry ID: ACTRN12620001334998; Pre-results. Trial Version: Version 1.1. Last updated 10 December 2020. |
| format | Article |
| id | doaj-art-8d2a8639023f420da72e1b23ca3e4ec2 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8d2a8639023f420da72e1b23ca3e4ec22025-08-20T01:47:33ZengBMJ Publishing GroupBMJ Open2044-60552022-05-0112510.1136/bmjopen-2021-059952Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial)Jane Turner0Nicolas H Hart1Patsy Yates2Laisa Teleni3Joanne F Aitken4Lee Jones5Steven M McPhail6Rahul Ladwa7Fiona Crawford-Williams8Raymond J Chan9Mark B Pinkham10Elizabeth P Pinkham11Brigid Hanley12Gemma Lock13Jodie Nixon14Oluwaseyifunmi Andi Agbejule15Carmen P Escalante16Pediatrics and Human Development, Michigan State University College of Human Medicine, East Lansing, Michigan, USA6 Caring Futures Institute, Flinders University, Adelaide, South Australia, Australia1 Centre for Healthcare Transformation, Faculty of Health, Queensland University of Technology (QUT), Brisbane, Queensland, Australia1 School of Nursing, Queensland University of Technology, Kelvin Grove, Queensland, AustraliaCancer Council Queensland, Brisbane, QLD, AustraliaPatient Advocate, Arlington, Virginia, USAAustralian Centre for Health Services Innovation & Centre for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, AustraliaPrincess Alexandra Hospital, University of Queensland, Brisbane, Queensland, AustraliaCentre for Health Research, University of Southern Queensland, Springfield, Queensland, Australia6 Caring Futures Institute, Flinders University, Adelaide, South Australia, Australia7 Radiation Oncology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia1 Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Queensland, Australia4 Cancer Council Queensland, Brisbane, Queensland, Australia4 Cancer Council Queensland, Brisbane, Queensland, Australia5 Occupational Therapy Department, Princess Alexandra Hospital, Brisbane, Queensland, Australia6 Caring Futures Institute, Flinders University, Adelaide, South Australia, Australia10 The University of Texas MD Anderson Cancer Center, Houston, Texas, USAIntroduction Cancer-related fatigue (CRF) is one of the most common and debilitating adverse effects of cancer and its treatment reported by cancer survivors. Physical activity, psychological interventions and management of concurrent symptoms have been shown to be effective in alleviating CRF. This pilot randomised controlled trial (RCT) will determine the feasibility of a telehealth CRF clinic intervention (T-CRF) to implement evidence-based strategies and assess the impact of the intervention on CRF and other clinical factors in comparison to usual care.Methods and analysis A parallel-arm (intervention vs usual care) pilot RCT will be conducted at the Princess Alexandra Hospital in Queensland, Australia. Sixty cancer survivors aged 18 years and over, who report moderate or severe fatigue on the Brief Fatigue Inventory and meet other study criteria will be recruited. Participants will be randomised (1:1) to receive the T-CRF intervention or usual care (ie, specialist-led care, with a fatigue information booklet). The intervention is a 24-week programme of three telehealth nurse-led consultations and a personalised CRF management plan. The primary objective of this pilot RCT is to determine intervention feasibility, with a secondary objective to determine preliminary clinical efficacy. Feasibility outcomes include the identification of recruitment methods; recruitment rate and uptake; attrition; adherence; fidelity; apathy; and intervention functionality, acceptability and satisfaction. Clinical and resource use outcomes include cancer survivor fatigue, symptom burden, level of physical activity, productivity loss, hospital resource utilisation and carer’s fatigue and productivity loss. Descriptive statistics will be used to report on feasibility and process-related elements additional to clinical and resource outcomes.Ethics and dissemination This trial is prospectively registered (ACTRN12620001334998). The study protocol has been approved by the Metro South Health and Hospital Services Human Research Ethics Committee (MSHHS HREC/2020/QMS/63495). Findings will be disseminated through peer-reviewed publications, national and international conferences and seminars or workshops.Trial registration number Australian New Zealand Clinical Trials Registry ID: ACTRN12620001334998; Pre-results. Trial Version: Version 1.1. Last updated 10 December 2020.https://bmjopen.bmj.com/content/12/5/e059952.full |
| spellingShingle | Jane Turner Nicolas H Hart Patsy Yates Laisa Teleni Joanne F Aitken Lee Jones Steven M McPhail Rahul Ladwa Fiona Crawford-Williams Raymond J Chan Mark B Pinkham Elizabeth P Pinkham Brigid Hanley Gemma Lock Jodie Nixon Oluwaseyifunmi Andi Agbejule Carmen P Escalante Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial) BMJ Open |
| title | Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial) |
| title_full | Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial) |
| title_fullStr | Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial) |
| title_full_unstemmed | Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial) |
| title_short | Telehealth cancer-related fatigue clinic model for cancer survivors: a pilot randomised controlled trial protocol (the T-CRF trial) |
| title_sort | telehealth cancer related fatigue clinic model for cancer survivors a pilot randomised controlled trial protocol the t crf trial |
| url | https://bmjopen.bmj.com/content/12/5/e059952.full |
| work_keys_str_mv | AT janeturner telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT nicolashhart telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT patsyyates telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT laisateleni telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT joannefaitken telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT leejones telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT stevenmmcphail telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT rahulladwa telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT fionacrawfordwilliams telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT raymondjchan telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT markbpinkham telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT elizabethppinkham telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT brigidhanley telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT gemmalock telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT jodienixon telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT oluwaseyifunmiandiagbejule telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial AT carmenpescalante telehealthcancerrelatedfatigueclinicmodelforcancersurvivorsapilotrandomisedcontrolledtrialprotocolthetcrftrial |