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A proactive and structured telephone based intervention to reduce carer burden and depression among carers of cancer patients

A Multi-centre randomized controlled trial to test the efficacy of a proactive and structured telephone based intervention to reduce carer burden and depression among carers of cancer patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000731796
Acronym
PROTECT
Enrollment
216
Registered
2013-07-02
Start date
2013-08-29
Completion date
2014-03-06
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is evaluating a proactive and structured telephone based intervention for carers of cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and a carer of a newly diagnosed cancer patient attending chemotherapy or radiotherapy treatment with curative intent. Trial details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the new telephone based intervention. This is a proactive and structured outcall program of information and support, delivered by experienced Cancer Council Helpline nurses to carers. The Helpline nurse screens carers for distress and links them to a range of community based supportive care services as required. Carers in this group will be contacted by a Cancer Council Helpline nurse at 7-10 days post referral (Outcall One), four weeks later (Outcall Two), and three months later (Outcall Three). Participants in the second group will receive three telephone outcalls at the same timepoints as group one. The purpose of the calls is to remind participants about the availability of the Cancer Helpline. Participants who choose to contact the Cancer Helpline will not receive the Outcall program but the usual support provided by cancer helpline nurses. Carers will complete questionnaires at Baseline, 1 month and 6 months, and patients will be complete questionnaires at Baseline and 1 month, in order to evaluate carer burden, psychological health, carers’ ability to navigate health services, quality of life, unmet needs, and cost-effectiveness.

Interventions

The intervention comprises: a) A proactive and structured Outcall program of information and support, delivered by experienced Cancer Council Helpline nurses to carers, that links them to a range of community based supportive care services as required; b) Screening carers for distress and refers those with elevated levels to their GP for follow up psychological services to reduce their burden and improve their psychological health. Participants randomised into the Intervention group will b

The intervention comprises: a) A proactive and structured Outcall program of information and support, delivered by experienced Cancer Council Helpline nurses to carers, that links them to a range of community based supportive care services as required; b) Screening carers for distress and refers those with elevated levels to their GP for follow up psychological services to reduce their burden and improve their psychological health. Participants randomised into the Intervention group will be contacted by a Cancer Council Helpline nurse as follows: Using a standardized protocol and check list, a Cancer Council Helpline nurse will telephone participants 7-10 days post referral (Outcall One), four weeks later (Outcall Two), with the third outcall (Outcall Three) three months later. For each outcall, seven Cancer Helpline outcall attempts over different times (eg 9am-1pm; 1pm-5pm; 5pm-6pm) across different week days over 2 weeks will be undertaken. After seven failed attempts and no response, a person will be declared ‘absent’ for a particular outcall. No further contact will be made until the next outcall is scheduled. All successful and failed attempts will be documented. Duration of each telephone call will be on average 20 minutes. During each of the three outcalls, the Helpline nurse will administer the Distress Thermometer (DT) and will then raise six items for further discussion during which tailored information, support and specific carer resources will be provided. The areas selected for discussion have been specifically chosen to achieve the intended outcomes of reduced carer burden, improved psychological health and quality of life and increased health literacy and ability to navigate the health system. The six areas that will be addressed are: 1) Psychological distress 2) Health literacy 3) Health 4) Family support 5) Financial support 6) Practical advice

Sponsors

Deakin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults, aged 18 years or more, who are carer / newly diagnosed cancer patient dyads, where the patient is attending cycle 2-5 of adjuvant chemotherapy or fraction 2-10 for radiotherapy treatment for cancer, who are able to complete English language questionnaires; cancer patients will be diagnosed with curative intent.

Exclusion criteria

Cognitive dysfunction of either the cancer patient or the carer in the dyad. Experienced health service oncology nurses will determine cognitive dysfunction, defined as overt psychotic illness or dementia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 25, 2026