Introduction
Methods
Design
Setting and participants
Recruitment procedure
Fatigue risk score
Sample size
Trial consent and randomisation
Trial interventions
Trial outcomes
Trial measures
Outcome measure | Pre-RT | Week 2 | Week 3 | + 10 days | + 3 weeks | + 6 months |
---|---|---|---|---|---|---|
Before RT treatment | After 10 RT treatments | End of RT treatment | 10 days after RT | 3 weeks after RT | 6 months after RT | |
T0 | T1 | T2 | T3 | T4 | T5 | |
Fatigue | X | X | X | X | X | X |
Anxiety | X | X | X | |||
Depression | X | X | X | |||
QoL | X | X | X | X | ||
Self-efficacy | X | X | X | X |
Data analysis
Results
Objective 1—Feasibility of trial design
Recruitment
Trial groups
Intervention (n = 21) | Control (n = 12) | All (n = 33) | |
---|---|---|---|
Mean (SD) | |||
Age (years) | 57.4 (10.2) | 60.1 (7.5) | 58.3 (10) |
Body mass index (kg/m2) | 29.2 (5.3) | 27.6 (5.6) | 28.6 (5.4) |
Index of multiple deprivation | 1212.8 (539.4) | 1023.6 (601.5) | 1143.9 (552.8) |
Time from surgery to radiotherapy (days) | 61.5 (12.2) | 61.0 (16.7) | 61.3 (13.7) |
Frequency (% of group) | |||
Work | |||
Retired/housewife Changed/postponed Continued work | 5 (24) 14 (66) 2 (10) | 7 (58) 4 (34) 1 (8) | 12 (36) 18 (55) 3 (9) |
Diagnosis | |||
Carcinoma in situ Invasive ductal cancer Invasive lobular cancer | 2 (10) 15 (71) 4 (19) | 1 (8) 8 (67) 3 (25) | 3 (9) 23 (70) 7 (21) |
Tumour/Node/Metastasis stage group | |||
0 I II III | 2 (10) 6 (29) 10 (48) 3 (13) | 1 (8) 5 (41) 5 (42) 1 (8) | 3 (9) 11 (33) 15 (46) 4 (12) |
Laterality | |||
Right Left | 13 (62) 8 (38) | 5 (42) 7 (58) | 18 (54) 15 (46) |
Grade | |||
1 2 3 | 1 (5) 9 (43) 11 (52) | 2 (17) 6 (50) 4 (33) | 3 (9) 15 (45.5) 15 (45.5) |
Surgical procedure | |||
Wide local excision Mastectomy | 19 (91) 2 (9) | 11 (92) 1 (8) | 29 (91) 3 (9) |
Chemotherapy | |||
Yes No | 14 (67) 7 (33) | 5 (42) 7 (58) | 19 (59.4) 13 (40.6) |
Travel mode for treatment | |||
Self Hospital transport | 21 (100) 0 | 12 (100) 0 | 33 (100) 0 |
Breast boost 10 Gy/5#/1 week | 1 (5) | 1 (8) | 1 (6) |
40 Gy/15#/3 weeks to SCF | 1 (5) | 0 | 1 (5) |
Trial retention and adherence to protocol
Objective 2—Acceptability of trial process and intervention
Trial process
The points at which the questionnaires had to be completed were very important points. They let me evaluate my response to the treatment. [Control2005]The paperwork was spread out so I didn’t have to do it all in one go when I was tired. [Intervention1095]
You think you’re getting over it but it actually starts getting worse. So I now understand why the questions are there. I thought, ‘this is what they’ve been talking about’, but you don’t know until it hits you. [Intervention1071]
I would have found it interesting talking with the counsellor. [Control2055]It would have been nice that somebody else was keeping an eye on me and getting me going. [Control1053]
Intervention fidelity and adverse effects
Acceptability of intervention
Theme | Illustrative quotes |
---|---|
Normalisation of fatigue … and rarely mentioned emotional and psychological effects. A sense of control facilitated by evaluating response to treatment | … it was comforting just to know that it’s okay, it’s normal and it will improve. You feel like you’re part of this big family. (1093) A better understanding of how tired I was feeling and how I was feeling about how tired I was feeling, and what I could do to manage my expectations or how I felt, that was the thing. You think that fatigue is a physical issue don’t you, but when you dig deeper I don’t think it is. It comes with the emotional side as well and the mood and I suppose there were broader issues really, but it was like I was trying to deal with it too head-on. And then when I was in the sessions it made me realise that perhaps it wasn’t just the physical side that struck me down. (1081) By writing and thinking, ‘Well, hang on, last time I was this but now I’m this’, you could see the difference because it messes with your memory and you can’t remember every day anyway. (1071) The intervention was brilliant because I was able to speak and look at coping mechanisms. It was a pattern, so perhaps when I did have energy and perhaps when I was feeling very tired, obviously being able to relate back to the diary then you could put coping mechanisms into place there. (1081) |
Technology motivates Activity tracker overcomes resistance to activity fear of fatigue, and sedentary behaviours | I loved having that active thing on my wrist. That was brilliant, I didn’t want to give that back. Because it made me – it challenged me to do more, to have a look at it and have a go, because I’d set it up on my tablet. Every day I’d have a look and “Wow, did I do that?” So that was like a challenge. (1114) The tracker made me go, “I’m going to do this many steps today”, but I only did that if I felt well enough to do it. But I always went out anyway. So that was an incentive to fight the risk of fatigue. (1071) There were times when it was reminding me to move, and I’d go, I don’t want to, but I think that is normal. I mean there were times when you’re sitting around waiting for the radiotherapy and travelling back there was a good 2 ½ hours when I really wasn’t able to be very active. Other than that, it did make me conscious of how long it had been since I had moved. There was at least one occasion where I went over 8000 and it had a little party on there! Subjectively I suppose it, it doesn’t feel like it’s getting any easier but if you go for a walk or a run or whatever but then, it’s nice to have something that tells you that you are going slightly faster than you were before or further, that kind of thing really. (1093) |
Caring for self Opportunity to prioritise self makes for a restorative effect | Just keep the one-to-one intervention because it was so refreshing to be able to talk to somebody that wasn’t directly connected to the treatment, but was in that environment. To have a dedicated session about things that might be worrying me around my activity levels. I suppose it gave me an opportunity to reflect more on what I was thinking and feeling, and how I was behaving. Although I am not sure it was always related to fatigue. (1060) Opening up, being able to say how you felt and I probably opened up too much, because I think I started talking about my life a little bit! But she was an amazing listener, that’s so important to have the right person to ask those questions. She was really brilliant, independent from the nurses—kind of like a friend. So yeah, it was far better than what I thought it was going to be, like I’ve mentioned the coping mechanisms that was needed to push myself that little bit further (1071) I would have just carried on doing as much as I could anyway but it made me stop and think about resting as well because I don’t always get the rest that I need (1114) I didn’t have a lot of enthusiasm for anything when I was going through this period. So it helped me focus on good things and get on with some of the activities that I enjoyed in the past, and had stopped doing while I was going through this treatment. (1060) |
Importance of identity Activity helps maintain self-identity when tailored to contexts | You’re feeling so tired and you feel you’ve lost, do you understand what I’m saying? You’re not being able to fulfil activities and things like that and I felt, not sure useless is the right word really but everything is an effort. Not feeling emotional just you’ve got heavy energy: probably useless is a good word to be honest. (1081) I did find I had a bit of strange obsession with ironing! Not that I did that much, but it was really agitating me that I wasn’t doing it. It is difficult to analyse yourself … I said, ‘I’m not going to give in to it’, because you can fight your way through it. If I sat down, I thought, “Oh God, I don’t want to get up”, but then we thought ‘No, I’m going to get up and I’m not going to let it beat me.’ (1093) When I returned to work I was surprised how tired I felt but we’d gone through some ways that can be managed. I’m still trying to follow that pattern of good health. I thought it was good that they had these exercise sessions geared towards people with cancer and I don’t think they do them locally but I know there’s an organisation in Y. (1060) |
I did find myself having to balance not doing any harm therapeutically by closing patients down when they would voice their concerns and distress about their ability not being able to do the things that they used to do and also delivering the intervention, as a proactive way to manage that and resume some level of activity.
Objective 3—Estimation of unknown parameters
Between-group comparisons of trial mseasures
T0 Baseline | T1 Week 2 | T2 Week 3 | T3 + 10 days | T4 + 3 weeks | T5 + 6 months | ||
---|---|---|---|---|---|---|---|
Measure | Mean (SD) 95% confidence interval Median (IQR) | ||||||
FACIT-F | |||||||
Intervention | 19.3 (8.8) 15.1–23.6 20 (9) | 20.0 (11.5) 14.8–25.6 18 (17) | 18.6 (9.9) 13.8–23.3 18 (14) | 18.8 (9.9) 14–23.6 18 (16) | 17.8 (10.5) 12.8–22.9 18 (17) | 17.1 (9.4) 10.4–23.8 17 (17) | |
Control | 19.6 (10.2) 12.3–26.9 19 (15) | 19.8 (9.1) 13.2–25.5 23 (17) | 21.0 (9.7) 14.4–27.5 25 (16) | 21.7 (10.7) 14.6–27.1 25 (25) | 19.3 (10.2) 12.4–26.1 26 (15) | 9.1 (9.0) 1.6–16.7 6 (18) | |
QLQ30 | |||||||
Intervention | 8.6 (2.0) 7.6–9.6 8 (3) | 8.8 (2.5) 7.6–9.9 8 (2) | 8.8 (2.8) 7.5–10.1 8 (3) | 8.5 (2.6) 6.7–10.4 8 (3) | |||
Control | 9.8 (4.2) 7.1–12.4 9 (7) | 8.3 (2.7) 6.5–10.1 8 (4) | 9.2 (3.5) 6.8–11.6 8 (5) | 7.3 (2.8) 4.9–9.6 6 (7) | |||
AH self-efficacy | |||||||
Intervention | 34.8 (12.9) 28.6–41.1 35 (17) | 40.8 (10.2) 35.9–45.7 41 (18) | 42.2 (10.7) 37.1–47.3 46 (19) | ||||
Control | 34.7 (7.3) 30.1–39.2 34 (11) | 38.8 (14.4) 29.1–48.5 39 (20) | 35.3(17.5) 23.5–47.1 30 (22) | ||||
HADS anxiety | |||||||
Intervention | 7.7 (4.2) 5.7–9.7 8 (4) | 6.6 (4.0) 4.6–8.5 6 (4) | 5 (3.9) 2.2–7.8 4 (8) | ||||
Control | 7.9 (3.1) 6.0–9.9 8 (6) | 8.5 (4.1) 5.7–11.2 9 (6) | 5.3 (4.7) 1.3–9.2 4.5 (6) | ||||
HADS depression | |||||||
Intervention | 5.8 (3.5) 4.2–7.5 6 (5) | 5.6 (3.7) 3.9–7.4 5 (5) | 5.6 (3.7) 3–8.2 5 (4) | ||||
Control | 5.6 (3.7) 3.3–7.9 6 (6) | 6.7 (3.7) 4.2–9.2 7 (8) | 3.9 (2.1) 2.1–5.6 3.5 (3) |
Performance of fatigue risk score
Whole group N = 50 | No chemo N = 27 | Chemo N = 23 | ||
---|---|---|---|---|
FRS v FACIT fatigue at 15# | ρ | 0.81 | 0.81 | 0.84 |
95%CI* | 0.65 to 0.91 | 0.53 to 0.96 | 0.64 to 0.95 | |
p | < 0.001 | < 0.001 | < 0.001 | |
FRS v FACIT fatigue at + 10 days | ρ | 0.74 | 0.79 | 0.75 |
95%CI* | 0.61 to 0.84 | 0.61 to 0.9 | 0.47 to 0.89 | |
p | < 0.001 | < 0.001 | < 0.001 |