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Psychological Intervention to reduce depression and anxiety in cancer patients undergoing chemotherapy

Psychological Intervention to reduce depression and anxiety in cancer patients undergoing chemotherapy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000493347
Enrollment
45
Registered
2008-09-30
Start date
2008-09-01
Completion date
Unknown
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 pilot study seeks to obtain preliminary data that addresses the questioon of whether psychological inteventions can improve coping for Cancer patients undergoing chemotherapy for the first time, which is often an uncomfortable process. From a mental health point of view "coping" is operationalised interms of depression, anxiety and perceived quality of life. The effect of the interventions on nausea - a common side effect of chemotherapy - is also being assessed. Also of interest is whether interventions requiring specific psychological training (i.e. cognitive behavioural therapy) add anything to the outcomes achieved by simple relaxation training which could be carried out by a wide range of health professionals.

Interventions

Intervention Group 1: Cognitive behavioural (CB) coping with behavioural relaxation (BR): (Requires delivery by specialist Psychology staff) Patients in the CB coping with BR condition will individually attend the clinic approximately 3-5 days prior to their first scheduled chemotherapy session, for a 90-minute CB coping session. The session will incorporate a tour of the clinic and information on the sequence of events that will transpire when the patient comes in for their first chemotherapy

Intervention Group 1: Cognitive behavioural (CB) coping with behavioural relaxation (BR): (Requires delivery by specialist Psychology staff) Patients in the CB coping with BR condition will individually attend the clinic approximately 3-5 days prior to their first scheduled chemotherapy session, for a 90-minute CB coping session. The session will incorporate a tour of the clinic and information on the sequence of events that will transpire when the patient comes in for their first chemotherapy session, including the relaxation protocol. The patient and their family will be shown a short video of a “coping model” undergoing chemotherapy. The Psychologist will be involved in assisting the patient to implement the strategies outlined in the video within the context of a CB coping framework. They will be encouraged to ask questions, liaise with their GP for support and will be given information on how to cope with specific side-effects. At each of the 5 chemotherapy sessions, up to 30 minutes will be spent review reviewing the CB coping session will be discussed and any questions or issues will be discussed within a CB model. In addition, at the patient’s first chemotherapy session, the BR protocol (a relaxation session of up to 30 minutes) will also be implemented as described below. Intervention Group 2: Behavioural relaxation (BR) only: (Can be delivered by nursing and allied health staff) Participants in the BR only condition will individually attend the clinic approximately 3-5 days prior to their first scheduled chemotherapy session, for a 30-minute teaching session on progressive relaxation and a tour of the clinic. During the first chemotherapy session, the patient will be guided through the progressive relaxation, followed by a guided imagery exercise to encourage a deeper state of relaxation. This process will take approximately 30 minutes. During the guided imagery phase a nurse will begin the drug infusion. After chemotherapy, the relaxation session will be brought to a close and the postchemotherapy dependent measures will be administered. The patient will be asked to practice the relaxation session at home. The second and third chemotherapy sessions will be identical to the first. During the fourth and fifth sessions, the patient will be instructed to self-administer the relaxation and guided imagery procedures. Patient’s performance in this condition is of interest due to its greater applicability and ease of implementation by staff (e.g., nurses). Chemotherapy occurs in "cycles" and varies somewhat between patients. Cycles generally include at least six separate attendances ("sessions") that may take between six and eighteen weeks to complete, depending on the individual's chemotherapy regime. i.e. some subjects will be attending chemotherapy weekly, whilst others may attend fortnightly or three-weekly. Thus the duration of the overall intervention will be between six and eighteen weeks. Finally it is important to note that the chemotherapy component of each session (attendance) can take between 30 minutes and five hours, depending on their regime. The CB and/or BR components each occupy 30 minutes during the early part of he chemotherapy session. When the BR or combined CB/BR intervention has concluded, subjects will be invited to continue to apply the coping techniques as and when required during any remaining time of their chemotherapy session.

Sponsors

Victorian Cancer Agency
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Individuals undergoing outpatient chemotherapy for cancer for first time. Austin Health patients only.

Exclusion criteria

acutely unwell, inability to participate in treatment, inability to complete measures

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026